[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"migraine-with-aura\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:migraine-with-aura":437},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,60,85,122,147,173,201,226,247,272,295,315,339,364,384,414],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100551403",false,"NCT06459635","Migraine Attack Pain Phase Prediction Study","Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine","PREDI-CRISIS","Inclusion Criteria:\n\n* Age between 15 years and 69 years.\n* Diagnosed with migraine by a headache neurologist and according to the criteria proposed by ICHD-3.\n* History of migraine of at least 1 year of evolution.\n* Normal neurological examination.\n* Have given your informed consent.\n* Be able to describe your clinical situation and the characteristics of your headache.\n* Have an average of 10 to 14 migraine days per month in the three months prior to inclusion (high-frequency episodic migraine).\n* User-level management capacity of \"smartphone\" type electronic devices.\n* Be able to complete two months of study follow-up.\n\nExclusion Criteria:\n\n* Presence of another type of headache, with the exception of headache due to excessive use of analgesic medication.\n* Cognitive deficiency or any other pathology that may prevent or make it difficult for the patient to perform the study correctly.\n* Neurological focus in the examination.\n* Pregnancy or breastfeeding period.\n* Patients with known heart disease or bronchopathy, Sjögren\\'s syndrome, diabetes mellitus, or hypo\u002Fhyperthyroidism.\n* Carriers of pacemakers, neurostimulators or any other electronic device that is considered to make the interpretation of biometric records difficult.\n* Anatomical problem that makes the use of the device impossible.\n* Patients in whom it is expected that a change in migraine preventive treatment or other usual treatment will be possible during the study period.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},70,"ESTIMATED","2 Months","OBSERVATIONAL","The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. of Headaches at the Hospital de La Princesa since 2013 together with the Complutense and Polytechnic University of Madrid. Their results have been reflected in various publications (Pagán J, et al. Sensors 2015; Gago-Veiga AB, et al. J Pain Res 2018) and have promoted the creation of several invention patents.",[27,28,29,30,31],"Migraine","Migraine Headache","Migraine Disorders","Migraine Without Aura","Migraine With Aura",[27,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Headache","Predict","Prediction","headache prediction","predict headache","migraine prediction","predict migraine","migraine attacks","migraine attack","headache attack","migraine attack prediction","predict migraine attack","prediction algorithm","algorithm","RECRUITING","2026-06-30",{"date":50,"type":51},"2026-07-02","ACTUAL",{"date":53,"type":51},"2023-10-09",{"date":55,"type":22},"2026-07",{"name":57,"class":58},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa","OTHER",1,{"id":61,"slug":4,"hasResults":10,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":83,"locationsCount":59},"100643927","NCT07667621","A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department","A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department","Inclusion Criteria:\n\n* • At least 18 years of age\n\n  * Capacity to provide informed consent (without a Representative)\n  * Emergency Department presentation for a headache consistent with migraine, based either on the treating clinical team's judgement, or fulfillment of International Classification of Headache Disorders (ICHD-3) criteria for migraine without aura or with typical aura, or for probable migraine without aura or with typical aura. It is acceptable if current headache duration is \\>72 hours. Must have been headache free for \\>48 hours prior to current attack.\n  * Willing to participate in post-discharge telephone assessments\n  * English and\u002For Spanish speaking patients\n\nExclusion Criteria:\n\n* • Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant.\n\n  * Use of analgesics or abortive headache medications within 60 minutes of study medication administration\n  * Use of the following drug\u002Ffood categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors\u002Finducers, 5) NTCP transporter potent inhibitors\u002Finducers\n  * History of ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable\n  * History of any stroke within 3 months, or any lifetime stroke and age ≥65 years\n  * History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate\n  * History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)\n  * History of severe hepatic impairment, as assessed by the investigator or qualified delegate\n  * History of kidney disease stage 4 (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n  * History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients\n  * Lifetime use of CGRP-targeting acute or preventive migraine medications\n  * In custody of law enforcement\n  * Current pregnancy or lactation\n\n    * All individuals of childbearing potential must have a negative pregnancy test at screening (urine or serum).\n    * A person is considered to be of childbearing potential if possessing female reproductive organs at birth, post-menarchal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no cause identified other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).",{"count":67,"type":22},100,"INTERVENTIONAL",[70],"PHASE1","Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials.",[27,73,74,28,75,30,31],"Migraine Disease","Migraine in Adults","Acute Migraine","NOT_YET_RECRUITING","2026-06-20",{"date":79,"type":51},"2026-06-25",{"date":55,"type":22},{"date":82,"type":22},"2027-08",{"name":84,"class":58},"University of South Florida",{"id":86,"slug":4,"hasResults":10,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":10,"sex":17,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":68,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100417438","NCT04715685","Mind Body Balance for Pediatric Migraine","Inclusion Criteria:\n\n* Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders(ICHD) criteria\n* Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 4 and ≤ 28.\n* PedMIDAS: PedMIDAS Disability Score \\> 4, indicating at least mild disruption in daily activities and \\\u003C 140, indicating extreme disability that may require more comprehensive, multi-component therapy\n* Use of one or more of the following prescribed nutraceuticals and\u002For preventive anti-migraine medications at the time or randomization or be on a stable dose of one or more of the following throughout the 12 weeks of the study \\[Vitamin B2 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3 (Erocalciferol\u002FCholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)\\]\n* Language: English speaking, able to complete interviews and questionnaires in English\n\nExclusion Criteria:\n\n* Continuous migraine defined as unrelenting headache for a 28 day period\n* Must agree not to take non-specific acute medication, such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month (to prevent medication overuse headache)\n* PedMIDAS Disability Score \\> 140, indicating extreme disability that may require more comprehensive, multi-component therapy\n* Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)\n* Present severe psychiatric disease, alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) or other circumstances, that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study","10 Years","17 Years",{"count":93,"type":22},260,[95],"NA","This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.",[33,98,99,27,29,31,30,100],"Headache Disorders","Headache, Migraine","Chronic Migraine",[102,103,104,105,106,107,108,109,110,111],"headache","migraine","cognitive behavioral therapy","pediatrics","mind body intervention","diaphragmatic breathing","progressive muscle relaxation","imagery","relaxation","biofeedback","2026-06-14",{"date":114,"type":51},"2026-06-16",{"date":116,"type":51},"2021-03-09",{"date":118,"type":22},"2026-11-30",{"name":120,"class":58},"Children's Hospital Medical Center, Cincinnati",2,{"id":123,"slug":4,"hasResults":10,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":68,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":59},"100642224","NCT07642414","A Comprehensive Digital Care Program for Migraine Management","Evaluation of a Comprehensive Digital Care Program for Migraine: A Prospective, Single-Arm, Pilot Study","Inclusion Criteria:\n\n* 18 years of age or older\n* Documented or clinical history of episodic or chronic migraine (with or without aura) for at least 12 months, consistent with ICHD-3 criteria. Verification of diagnosis must be established using one or more of the following methods: participant-provided medical records, documented pharmacy prescription history, or validated diagnostic screening instruments.\n* Passes ID-Migraine Screener with a score of 2 or more \"yes\" answers to the following question: During the last 3 months, did you experience any of the following with your migraines? (1) Your migraines limited your ability to complete your daily activities for more than one day; (2) You felt nauseated or sick to your stomach; (3) Light bothered you (a lot more than when you don't have migraines).\n* Migraine onset occurred at age 50 years or younger\n* Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary\n* At least 80% eDiary compliance (minimum of 22 out of 28 days) during the prospective baseline run-in period\n* Currently on a stable dose of traditional oral migraine preventive medication (e.g., topiramate, beta-blockers, amitriptyline) for at least 90 days prior to the start of the 28-day baseline period, or taking no preventive medication\n* Currently on a stable dose of CGRP monoclonal antibodies (e.g., Aimovig, Emgality, Ajovy, Vyepti) or OnabotulinumtoxinA (Botox) for at least 180 days (6 months) prior to the start of the 28-day baseline period\n* Willingness to maintain current preventive and as-needed (acute) medication regimens (e.g., triptans, NSAIDs, or abortive gepants) and refrain from initiating any brand new pharmacological or clinical treatments (e.g., nerve blocks, Botox, or infusions) for the duration of the 12-week intervention period\n* Sufficient physical mobility to engage with the exercise therapy component of the program, with or without reasonable accommodations; participants reporting significant mobility restrictions (e.g., wheelchair use) will be eligible pending a clinical safety review by a Study Physician or Physical Therapist\n* Active commercial health insurance coverage (either as the primary policyholder or a covered dependent) through an employer-sponsored health plan, commercial health insurer, or an affiliated benefit partner eligible for digital health solution deployment\n* US resident\n* Has a valid email account\n* Personal ownership of a smartphone (iOS 15 or later, or Android 10 or later) with Bluetooth capability, app store access, and compatibility with the eDiary\n* Able to understand and provide voluntary informed consent\n\nExclusion Criteria:\n\n* Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device\n* Presence of a metal implant in the head or neck (excluding dental work)\n* Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period\n* Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note: Medication Overuse Headache (MOH) is NOT an exclusion criterion\n* History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal Investigator and\u002For Study Physician, would make the exercise therapy component of the program unsafe; History of major cardiovascular events (e.g., stroke, arrhythmia, myocardial infarction)\n* History of major migraine complications (e.g., migrainous infarction or aura-triggered seizure)\n* Presence of fever, chills, or night sweats lasting five or more days and not improving\n* Significant change in headache pattern, including headaches that are becoming much more severe or frequent, represent a new type of pain, wake the participant from sleep, or worsen with positional changes (e.g., coughing, bearing down, or changing position)\n* Recent changes in vision, mental status, sensation, or strength; or new onset of jaw pain or neck stiffness\n* Unexplained significant weight loss (past 3 months), or persistent weakness\u002Fnumbness in the extremities (past 3 months)\n* Known history of conditions that may compromise the immune system\n* Head trauma within the past 2 weeks or diagnosis of a spinal fracture or shoulder dislocation within the past 3 months\n* Any major trauma, fracture, or significant injury (e.g., car accident, sports injury) within the past 3 months\n* Any major surgery within the past 3 months\n* Inability to stand up from a chair without assistance (unless the participant utilizes a wheelchair and has been cleared via PT review)\n* History of falling due to balance, weakness, vision, or other physical limitations within the past 3 months\n* Current diagnosis of epilepsy or active malignancy (history of cancer within the last 5 years)\n* Presence of a cognitive or neurological disorder (e.g., dementia, Parkinson's disease) that may interfere with study participation\n* Currently unmanaged psychiatric disorder (e.g., schizophrenia, substance abuse, or severe major depressive disorder\u002Fanxiety) that, in the opinion of the investigator, could prevent compliance with study instructions\n* Pregnant, planning to become pregnant during the study, or currently breastfeeding\n* Currently institutionalized\n* Insufficient proficiency with the English language to take part in study procedures or complete online surveys\n* Current or previous enrollment in any Hinge Health Program or participation in prior Hinge Health research studies\n* Current ownership or previous use of an Enso device or other prescribed high-frequency electrical stimulation therapy for the treatment of pain\n* Participation in an investigational study within 30 days prior to screening\n* Planned travel outside of the U.S. within the first month of enrollment\n* Current employees or contractors of Hinge Health, Inc. or L\\&E Research, and their immediate family members",{"count":129,"type":22},140,[95],"This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an FDA-cleared neuromodulation wearable device (Enso), personalized exercise therapy, and a dedicated care team, in reducing migraine frequency among adults with episodic or chronic migraine.",[27,31,30],[103,134,135,136,137],"transcutaneous electrical nerve stimulation","neuromodulation","digital health","exercise therapy","2026-06-12",{"date":114,"type":51},{"date":141,"type":22},"2026-06",{"date":143,"type":22},"2026-11",{"name":145,"class":146},"Hinge Health, Inc","INDUSTRY",{"id":148,"slug":4,"hasResults":10,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":155,"studyType":24,"phases":4,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":121},"100547581","NCT06409832","RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment","RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)","RAISE","Inclusion Criteria:\n\n* Diagnosis of migraine without aura or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);\n* At least 4 monthly migraine days;\n* Good compliance to study procedures;\n* Availability of headache diary at least of the preceding months before enrollment.\n\nExclusion Criteria:\n\n* Subjects with contraindications for use of gepants;\n* Diagnosis of chronic migraine\n* Concomitant diagnosis of medical diseases and\u002For comorbidities that, in the Investigator's opinion might interfere with study assessments;\n* medical comorbidities that could interfere with study results;\n* Pregnancy and breastfeeding.\n* Changes in preventive treatments in the month before the first administration of rimegepant",{"count":67,"type":22},"2 Years","The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.",[27,31,30],[33,159,160,161,162,163],"Medication overuse headache","Pain","Migraine prevention","Gepant","Rimegepant","2026-06-09",{"date":166,"type":51},"2026-06-11",{"date":168,"type":51},"2024-03-26",{"date":170,"type":22},"2027-09",{"name":172,"class":58},"University of Florence",{"id":174,"slug":4,"hasResults":10,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":68,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100638204","NCT07599228","Using Virtual Reality to Teach Mindfulness to People With Migraine","Migraine Intervention Using Reality-Assisted Guided Experience","MIRAGE","Inclusion Criteria:\n\n* Adults aged 18-80\n* Diagnosed with episodic migraine and experience 4-10 migraine days\u002Fmonth\n* On a stable dose of CGRP mAb for three months prior\n* Satisfy 4 week run-in of 4-10 headaches\u002Fmonth\n* Not taking other preventive medications\n* Not pregnant, breastfeeding, or planning to become pregnant within study timeframe\n* Able and willing to use VR device\n* No history of significant psychiatric illness\n* Willing to comply with study procedures\n* English-speaking\n\nExclusion Criteria:\n\n* Medication overuse (\\>10 days\u002Fmonth)\n* Vertigo\u002Fvestibular dysfunction\n* Active psychiatric or neurological comorbidities\n* Pregnancy, breastfeeding or planning pregnancy within study timeframe\n* Significant visual\u002Fhearing\u002Fmobility impairment affecting VR use","80 Years",{"count":182,"type":22},160,[95],"The aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.",[29,31,30,186],"Episodic Migraine",[188,103,189,190,191],"acceptance and commitment therapy (ACT)","virtual reality","mindfulness","Calcitonin Gene-Related Peptide monoclonal antibody therapy","2026-05-14",{"date":194,"type":51},"2026-05-20",{"date":55,"type":22},{"date":197,"type":22},"2031-01",{"name":199,"class":58},"Brigham and Women's Hospital",3,{"id":202,"slug":4,"hasResults":10,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":206,"targetDuration":4,"studyType":68,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":121},"100563566","NCT06617832","Trial Designs for Evaluating Migraine Treatment","Inclusion Criteria:\n\n1. Adults (18-65 years)\n2. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria\n3. Known episodic migraine (≥ 1 and \\< 15 headache days with features of migraine on at least 2-8 days per month for \\> 3 months) with and without aura and diagnosed before age 50\n4. Previous or active use of triptans as acute treatment for migraine\n5. Ability to speak and read Danish\n\nExclusion Criteria:\n\n1. Chronic migraine or history of chronic migraine in the last 12 months\n2. Other concomitant primary headache types except for infrequent tension-type headache\n3. Secondary headache disorders including medication overuse headache\n4. Severe psychiatric, vascular or liver diseases\n5. Opioid or barbiturate use in the month preceding screening\n6. Current use of preventive migraine treatment (i.e., onabotulinum toxin A, and\u002For Calcitonin gene-related peptide (CGRP) monoclonal antibodies) (however, stable medical treatment with other migraine prophylactic agents is permitted, e.g. antidepressant, calcium channel blockers, beta blockers and antiepileptic drugs, 4 weeks prior to inclusion until the completion of participation in the study)\n7. Contraindications or inability to tolerate triptans\n8. Current substance use disorder\n9. Implanted metallic or electronic device in the head\n10. Cardiac pacemaker or implanted or wearable defibrillator\n11. Use of illegal psychotropic drugs less than a week before participation in the study; regarding cannabis: less than four weeks before participation in the study\n12. Current pregnancy or planned pregnancy (confirmed by pregnancy test and by use of safe contraception as defined by the Danish Medicines Agency) and lactation",{"count":207,"type":22},128,[95],"The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, advanced balanced placebo design, patients with episodic migraine will receive six treatment conditions in a randomized order.",[31,30,99],[33,212,213,214,215,216],"Episodic migraine","Randomized controlled trial","Balanced placebo design","Treatment effects","Adverse events","2026-04-08",{"date":219,"type":51},"2026-04-13",{"date":221,"type":51},"2024-11-13",{"date":223,"type":22},"2028-09",{"name":225,"class":58},"University of Aarhus",{"id":227,"slug":4,"hasResults":10,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":10,"sex":17,"minAge":90,"maxAge":91,"enrollmentInfo":232,"targetDuration":4,"studyType":68,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100507610","NCT05889624","Responding With Evidence and Access for Childhood Headaches","Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)","Inclusion Criteria:\n\n* Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)\n* Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization\n* Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine\n* English fluency: Able to complete the study visits and questionnaires in English\n\nExclusion Criteria:\n\n* Current treatment includes amitriptyline and\u002For CBT specific to headache care\n* Current prescribed preventive antimigraine medication within a period equivalent to \\\u003C 5 half-lives of that medication before entering the baseline phase\n* Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention\n* Youth who are pregnant\n* Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis\n* Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant",{"count":233,"type":22},400,[95],"This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.",[33,98,99,27,29,31,30,100],[102,103,104,105,107,108,109,110,111],"2026-03-04",{"date":240,"type":51},"2026-03-06",{"date":242,"type":51},"2023-08-22",{"date":244,"type":22},"2027-12-31",{"name":120,"class":58},15,{"id":248,"slug":4,"hasResults":10,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":59},"100619775","NCT07349004","Neurogenetic And Hemodynamic Of Migraine Aura And Pfo","Association Between PFO and Migraine With Aura: A Case-Control Observational Study With Genetic and Neurosonological Analysis","PFOCUS","Inclusion Criteria:\n\n* Diagnosis of migraine with aura (according to Chapter 1.2 of the International Classification of Headache Disorders, 3rd edition \\[ICHD-3\\])\n* Age ≥ 18 years\n* Both sexes\n* Obtained written informed consent to participate in the study\n\nExclusion Criteria:\n\n* History of congenital heart disease",{"count":255,"type":22},240,"The PFOCUS Study aims to clarify the relationship between patent foramen ovale (PFO) and migraine with aura (MA). Patients diagnosed with MA according to ICHD-3 criteria will be classified as cases (PFO+) or controls (PFO-) based on the presence or absence of a right-to-left shunt detected by transcranial Doppler or a previously documented PFO. The study will enroll 240 adult participants over 36 months.\n\nThe primary objective is to determine whether genetic variants differ significantly between patients with MA with and without PFO. Secondary objectives include assessing cerebral blood flow regulation and platelet function in patients with MA with and without PFO.\n\nParticipants will undergo a single study visit including the collection of demographic and clinical data and a comprehensive neurosonological assessment. This will include microembolic signal counts, cerebrovascular reactivity testing, and a contrast-enhanced transcranial Doppler study for shunt detection. Blood samples will be collected for whole-exome sequencing (with a focus on NOTCH3 and an expanded gene panel) and for platelet aggregometry.\n\nThe study is expected to provide new insights into the biological mechanisms linking PFO and MA-potentially involving endothelial dysfunction, altered vascular smooth muscle responses, or platelet activation-thereby informing prevention strategies and guiding future research.",[31],[259,260,261],"patent foramen ovale","migraine with aura","CADASIL","2026-02-09",{"date":264,"type":51},"2026-02-11",{"date":266,"type":51},"2025-11-24",{"date":268,"type":22},"2028-11",{"name":270,"class":271},"Azienda Usl di Bologna","OTHER_GOV",{"id":273,"slug":4,"hasResults":10,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":68,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":4},"100577344","NCT06797076","App-Based Migraine Treatment: The Health enSuite Study","Evaluating an App-Based Treatment for Migraine: The Health enSuite Migraine Study","Inclusion Criteria (for study entry):\n\n* Fluent in English\n* Age 18 to 50 years\n* Regular access to an internet-connected device (e.g., smartphone, tablet, or computer)\n* Scores 2 or more on the ID Migraine Screener\n\nInclusion Criteria (for enrollment):\n\n* Completes at least 50% of the daily entries when asked to use the migraine headache tracker for a 28-day period\n* Experiences migraine headache on at least 4 days, but no more than 20 days, within the past month (based on diary data)\n\nExclusion Criteria:\n\n* Diagnosis of psychosis and\u002For schizophrenia\n* Physical or cognitive impairment that compromises ability to provide informed consent\n* Pregnancy, planning pregnancy during the study, or currently breastfeeding\n* Change in medications and\u002For dietary supplements (herbal supplements, minerals, vitamins) for migraine headache pain in the past month\n\nRationale for Eligibility Criteria:\n\nBehavioural and\u002For psychosocial treatment is not recommended for migraine headache related to conditions such as psychosis, and\u002For schizophrenia. While behavioral and psychosocial treatments may offer some benefits for individuals with migraine headache related to psychosis and schizophrenia, there are also potential risks to consider. For example, CBT may involve exploring painful feelings and experiences, which could be distressing for individuals with psychosis. This could potentially exacerbate psychotic symptoms or lead to emotional distress. Additionally, some individuals with schizophrenia may have difficulty engaging in CBT due to cognitive impairments, such as difficulty concentrating or remembering information, or paranoia. Therefore, potential participants who have any of these conditions will be excluded from the study.\n\nPregnancy and breastfeeding result in hormonal changes that can increase migraine headache symptoms. Thus, guidelines for headache trials highly suggest excluding participants who are planning to be pregnant, currently pregnant or are nursing their infants.\n\nThe initiation of other treatments for migraine headache at the same time as Health enSuite Migraine could jeopardize the interpretation of the trial results. They are permitted to continue using any pre-existing treatments (medications, dietary supplements, vitamins). If participants are taking any medications\u002F and or dietary supplements, they must have been taking them for at least one month to be eligible for enrollment in the trial. Participants are asked at the end of the trial if they have started any new medication while using Health enSuite Migraine; if the new medication taken is recognized to have impacted the results, the participant's data will be removed for data analysis.\n\nThe age range of 18-50 years was chosen to align with the typical demographic most affected by migraine headache and to ensure the app's design and content are appropriate for its intended users. Research indicates that migraine headaches are most prevalent in this age group, with peak incidence occurring during early adulthood and middle age. Additionally, individuals outside this range, such as adolescents or older adults, may have distinct physiological, psychological, and treatment needs that differ from those of the target demographic.\n\nFor example, older adults often experience migraine headache differently due to age-related comorbidities or medication interactions, which may require specialized interventions beyond the scope of this study or app. Similarly, the app's features and usability are tailored to adults with regular access to technology and familiarity with app-based interventions.\n\nThe Health enSuite Migraine program being tested in this trial requires the use of an internet-connected device. Health enSuite Migraine can be accessed through the web browser on an electronic device with an internet connection. People who do not have regular access to an internet-connected device are unlikely to benefit from Health enSuite Migraine, and therefore they will be excluded.\n\nParticipants must have experienced migraine headache pain at least four days out of each month. This criterion is intended to ensure that all participants will experience at least some migraine headache symptoms throughout the study. Chronic daily migraine headaches are especially difficult to treat through psychosocial intervention alone, therefore participants who report migraine headache on more than 20 days per month will be excluded. Apart from the above mentioned 8 criteria points, study eligibility will be evaluated based on one month of daily migraine headache tracking completed at baseline to ensure the participant experiences a migraine headache between 4 to 20 days within the past month","50 Years",{"count":280,"type":22},415,[95],"Health enSuite is a suite of applications designed by our research team at the Centre of Research in Family Health at IWK Health. These applications evaluate virtual solutions for clinical problems and assist family doctors with their adult patients.\n\nHealth enSuite will be utilized by Canadian family physicians targeting insomnia, anxiety, migraine headache, and caregiver distress.\n\nHealth enSuite Migraine has been designed to make cognitive and behavioral techniques for managing migraine headache readily available to primary care patients. The online program combines treatment elements that are effective in preventing and managing migraine headache pain, including trigger management, stress management, relaxation techniques, cognitive reappraisal, and psychoeducation.",[27,31,30],[33,27,285],"Cognitive Behavioral Therapy","2026-01-26",{"date":288,"type":51},"2026-01-27",{"date":290,"type":22},"2026-02-15",{"date":292,"type":22},"2027-06-02",{"name":294,"class":58},"IWK Health Centre",{"id":296,"slug":4,"hasResults":10,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":121},"100508638","NCT05903027","Gepant treAtments: EffectIveNess and tolERability (GAINER)","Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)","GAINER","Inclusion Criteria:\n\n* Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).\n* At least 3 MMDs\n* Good compliance to study procedures\n* Availability of headache diary at least of the preceding months before enrollment\n\nExclusion Criteria:\n\n* Subjects with contraindications for use of gepants;\n* Concomitant diagnosis of medical diseases and\u002For comorbidities that, in the Investigator's opinion might interfere with study assessments;\n* medical comorbidities that could interfere with study results;\n* Pregnancy and breastfeeding.",{"count":67,"type":22},"The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as acute migraine treatment in a cohort of episodic or chronic migraine patients.",[27,31,30,100],[33,159,160,162,306],"Triptan","2026-01-19",{"date":309,"type":51},"2026-01-21",{"date":311,"type":51},"2023-06-15",{"date":313,"type":22},"2026-09-15",{"name":172,"class":58},{"id":316,"slug":4,"hasResults":10,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":321,"targetDuration":4,"studyType":68,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":4},"100619259","NCT07342296","Induction of Migraine Attacks With Aura Using Pituitary Adenylate Cyclase Activating Polypeptide-38","Induction of Migraine Attacks With Aura Using Pituitary Adenylate Cyclase Activating Polypeptide-38: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 18 to 65 years of age upon entry into screening\n* History of migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria\n* ≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening\n* Provision of informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n* Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache\n* History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion\n* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior\n* Female subjects of childbearing potential with a positive pregnancy test during any study visit\n* Cardiovascular disease of any kind, including cerebrovascular diseases Hypertension (systolic blood pressure of ≥150 mmHg and\u002For diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day Hypotension (systolic blood pressure of ≤90 mmHg and\u002For diastolic blood pressure of ≤50 mmHg)\n* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion\n* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start\n* Headache of any intensity within 48 hours of infusion start\n* Aura within 48 hours of infusion start",{"count":322,"type":22},21,[95],"Pituitary Adenylate Cyclase Activating Polypeptide-38 (PACAP-38) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether PACAP-38 administration can trigger aura in individuals with a diagnosis of migraine with aura.",[31,326],"Migraine Aura",[103,328,329],"aura","Pituitary Adenylate Cyclase Activating Polypeptide-38","2026-01-08",{"date":332,"type":51},"2026-01-15",{"date":334,"type":22},"2026-02-01",{"date":336,"type":22},"2026-12-30",{"name":338,"class":58},"Danish Headache Center",{"id":340,"slug":4,"hasResults":10,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":345,"targetDuration":4,"studyType":68,"phases":347,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100367381","NCT04063540","Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura","APAM","Inclusion Criteria:\n\n* Diagnosis of migraine with aura code\n* At least 1 aura with aura per month in the 3 months prior to inclusion\n* No prophylactic antimigraine treatment for at least 1 month prior to inclusion\n* For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study\n* Signature of written informed consent\n* Patient affiliated with Social Security\n\nExclusion Criteria:\n\n* Existence of contraindication to taking amiloride:\n\n  * Known hypersensitivity to the molecule\n  * Hyperkalemia (potassium level (\\> 5.5 mmol \u002F l))\n  * Use of another hyperkalemic diuretic or potassium salts\n  * Renal insufficiency (clearance \\\u003C60 ml \u002F min)\n  * Severe hepatocellular insufficiency\n  * In combination with lithium, converting enzyme inhibitors, angiotensin II inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes\n* Cardiovascular and renal history, for subjects over 75 years old\n* Patient, who from an investigator's point of view would not be compliant to the procedure of the study\n* Pregnant or lactating patient\n* Patient under trusteeship, under guardianship, protected by law",{"count":346,"type":22},40,[348],"PHASE2","Recent data suggest involvement of Acid-Sensing Ion Channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. The implication of Acid-Sensing Ion Channels is discussed through Acid-Sensing Ion Channel-1 which is the most expressed Acid-Sensing Ion Channel channel subtype in the central nervous system. In a mouse model, cortical spreading depression is inhibited by different Acid-Sensing Ion Channel blockers including amiloride which is a non-selective blocker of the Acid-Sensing Ion Channel-1 channel. From a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. The APAM study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. This is a randomized crossover study versus placebo conducted in 3 French headache centers.",[31],[103,328,352,353],"Amiloride","acid-sensing ion channel","2025-11-27",{"date":356,"type":51},"2025-12-04",{"date":358,"type":51},"2020-08-11",{"date":360,"type":22},"2027-12",{"name":362,"class":58},"Centre Hospitalier Universitaire de Nice",5,{"id":365,"slug":4,"hasResults":10,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":370,"targetDuration":4,"studyType":68,"phases":371,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":59},"100594623","NCT07021859","Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide","Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 18 to 65 years of age upon entry into screening\n* History of migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria\n* ≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening\n* Provision of informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n* Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache\n* History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion\n* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior\n* Female subjects of childbearing potential with a positive pregnancy test during any study visit\n* Cardiovascular disease of any kind, including cerebrovascular diseases\n* Hypertension (systolic blood pressure of ≥150 mmHg and\u002For diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day\n* Hypotension (systolic blood pressure of ≤90 mmHg and\u002For diastolic blood pressure of ≤50 mmHg)\n* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion\n* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start\n* Headache of any intensity within 48 hours of infusion start\n* Aura within 48 hours of infusion start",{"count":322,"type":22},[95],"Calcitonin gene-related peptide (CGRP) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether CGRP administration can trigger aura in individuals with a diagnosis of migraine with aura.",[326,31],[27,375,376],"Aura","Calcitonin gene-related peptide","2025-08-03",{"date":379,"type":51},"2025-08-06",{"date":381,"type":51},"2025-06-27",{"date":336,"type":22},{"name":338,"class":58},{"id":385,"slug":4,"hasResults":10,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":16,"sex":17,"minAge":391,"maxAge":392,"enrollmentInfo":393,"targetDuration":395,"studyType":24,"phases":4,"briefSummary":396,"conditions":397,"keywords":403,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":59},"100567944","NCT06674772","Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification","Fenotipado Molecular De Pacientes Con Migraña Según Edad Y Sexo a Través De La Cuantificación De CGRP En Saliva Para Realizar Medicina De Precisión: Estudio FAST","FAST","Inclusion Criteria:\n\n* Migraine patients according to ICHD-3 criteria\n* Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.\n\nExclusion Criteria:\n\n* Presence of any major medical or neurological illness.\n* Presence of any salivary gland malfunction.\n* Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment.\n* Active migraine preventive treatment.\n* Pregnant or breastfeeding female.","6 Years","75 Years",{"count":394,"type":22},440,"1 Day","Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.",[398,27,28,399,30,186,400,401,402],"Headache (Migraine)","Migraine with Aura","Chronic Migraine Headache","Chronic Migraine, Headache","Episodic Migraine Headache",[27,404,405],"CGRP","saliva","2024-11-11",{"date":221,"type":51},{"date":409,"type":51},"2022-11-29",{"date":411,"type":22},"2025-05",{"name":413,"class":58},"Hospital Universitari Vall d'Hebron Research Institute",{"id":415,"slug":4,"hasResults":10,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":10,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":420,"targetDuration":4,"studyType":68,"phases":422,"briefSummary":424,"conditions":425,"keywords":426,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100476470","NCT05484349","TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）","Safety and Efficacy of Oral Tizanidine Hydrochloride in Preventing Migraine Attacks in Adult Migraine Patients: a Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to participate in this study.\n\n1. The age at entry for trails involving adult subjects is 18-65 years (including both ends)；\n2. According to ICHD-3(Headache Classification Committee of the International Headache Society,2018), individuals should be diagnosed with migraine without aura and\u002For migraine with aura, and should have a history of at least 1 year;\n3. The age at first migraine onset should be \\\u003C50 years;\n4. Migraine attacks ≥ 4 days\u002Fmonth and \\\u003C 15 days\u002Fmonth within 3 months prior to screening period (Refer to the definition of migraine days);\n5. Within 3 months before entering the screening period, the number of headache (including migraine and other types of headache) attack days per month is less than 15 days\u002Fmonth (Refer to the definition of headache days);\n6. Be willing to take effective contraceptive measures during the period of participating in this experiment and within 28 days after the last time taking investigational product;\n7. Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the baseline period.\n\n   The following criteria must be met during the baseline period to be eligible for entering the randomized, double-blind, placebo-controlled trial of the drug:\n8. Migraine days ≥4 and \\\u003C14 days within 4 weeks of baseline period(Evaluation based on the Annex 14.-Electronic Headache Diary);\n9. Headache days \\\u003C 14 days within 4 weeks of baseline period;\n10. Completion of at least 80% of the electronic diary within 4 weeks of the baseline period(Within 28 days of the baseline period, the electronic diary has been completed for at least 23 days), and the investigator believes that the subject is able to read, understand, and complete the study questionnaire and headache diary;\n11. Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the randomized, double-blind, placebo-controlled trials of the drug.\n\nExclusion Criteria:\n\nSubjects with any of the following cannot participate in this study:\n\n1. Subject diagnosed with possible migraine according to ICHD-3(2018);\n2. Current and previous diagnosis of primary headache, secondary headache, or painful cranial neuropathy other than migraine(diagnostic criteria are defined according to ICHD-3,2018);\n3. Previous use of more than two of the following 7 drugs is ineffective after adequate use, the types of these drugs are as follows:\n\n   * Type 1: Divalproex, Sodium Valproate\n   * Type 2: Topiramate\n   * Type 3: Beta blockers(such as: Atenolol, Bisoprolol, Metoprolol, Nadolol, Nebivolol, Pindolol, Propranolol, Timolol)\n   * Type 4: Tricyclic antidepressants(TCA) (such as: Amitriptyline, Nortriptyline, Protriptyline)\n   * Type 5: Serotonin-norepinephrine reuptake inhibitors (SNRIs) (such as: Venlafaxine, Desvenlafaxine, Duloxetine, Milnacipran)\n   * Type 6: Flunarizine, Verapamil\n   * Type 7: lisinopril, Candesartan\n   * Type 8: Drugs acting on the CGRP pathway（Monoclonal antibodies and Gepants）\n\n   Definition of treatment failure: No reduction in headache frequency, duration, or severity after 6 weeks of administration of the above drugs.\n\n   The following conditions are not defined as treatment failure:\n   * Lack of sustained response to medication;\n   * Can not be tolerated dose of drug\n4. Use of prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or therapies, etc. 2 months before the baseline period or during the baseline period (more details are in Prohibited Drugs\u002FTreatments);\n5. Subjects who intend to undergo head, face or neck injections of therapeutic or cosmetic Botulinum Toxin(such as Dysport, Botox, Xeomin, Myobloc and JeuvwauTM) during the study period or within 4 months before screening;\n6. Simultaneous use of two or more drugs that may have migraine preventive effects within 2 months before the start of the baseline period or during the baseline period (more details are in Annex- The List of Migraine Preventive Medications ) (If only one prophylactic drug is used, the dose must be stable for the two months prior to the baseline period and throughout the study);\n7. The following occurred within two months prior to the start of the baseline period:\n\n   * Taking Ergotamines or Triptans for ≥10 days per month, or\n   * Taking NSAIDs alone for ≥15 days compound or preparation of NSAIDs≥10 days, or\n   * Taking Opioid or Barbiturate analgesics for ≥4 days per month\n8. Fluvoxamine, ciprofloxacin (cytochrome oxidase P450IA2 inhibitor), fluoroquinolones, zileuton, antiarrhythmics (amiodarone, mexiletine, propafenone, and verapamil) , cimetidine, famotidine, acyclovir, ticlopidine, metoprolol, propranolol and other beta-blockers, clonidine and other alpha2-adrenergic agonists , Chinese patent medicine, Chinese herbal medicine, instrument or program (see 5.7.2 Prohibited Drugs\u002FTreatment for details)\n9. Subject has active chronic pain syndrome (eg, fibromyalgia, chronic pelvic pain, facial pain, etc.);\n10. Subject has a history of mental illness (eg, schizophrenia or bipolar disorder) or PHQ-9 score≥15；Subjects PHQ-9 score\\\u003C15 are allowed to enter the double-blind treatment period if they had a history of anxiety or depression and were taking no more than one psychotropic drug (excluding contraindicated drugs) (Subjects must have taken a stable therapeutic dose within 3 months prior to the baseline period);\n11. Have a serious neurological disorder other than migraines (Note: Do not rule out single children febrile convulsion);\n12. Patients with a history of malignant tumour within five years prior to the screening period, excluding non-melanoma skin cancer, cervical or breast ductal carcinoma in situ;\n13. The screening period meets any of the following laboratory values:\n\n    * Alanine transaminase (ALT) or aspartate aminotransferase (AST) \\>1.5×（upper limit of normal, ULN）, or\n    * Total bilirubin(TBIL) \\>1.5×ULN （Subjects with diagnosed Gilbert syndrome excluded）,or\n    * The creatinine clearance rate is less than 25 mg\u002Fmin, and the creatinine clearance rate decreases by 50%;\n14. Previous heart disease, heart failure, bradycardia, orthostatic hypotension and other types of hypotension, stroke, transient ischemic attack (TIA);\n15. The subject has factors that the investigator believes may put the subject at significant risk or may confound the results of the study; The subject has any medical or other reasons for being unfit to participate in the study;\n16. According to clinical interviews or C-SSRS questionnaires, the researcher believes that the subject is at risk of self-harm or harm to others;\n17. Within 12 months before the screening period, according to the subject's medical records or the subject's self-reported history of drug or alcohol abuse;\n18. Subjects expected to be pregnant or breastfeeding during the study period, or had a positive urine pregnancy test result at screening;\n19. During the study period, female subjects of childbearing potential were reluctant to use an acceptable method of effective contraception; Infertile women are defined as follows:\n\n    * Have a history of menopause, defined as: Age: ≥55 years old, Menopause ≥12 months, or Age:\\\u003C55 years old, no spontaneous menstruation for at least 2 years，or Age:\\\u003C55 years old, have spontaneous menstruation in the past 1 year, but current is amenorrhea (spontaneous or secondary to hysterectomy), and abnormal postmenopausal Gonadotropin levels: luteinizing hormone(LH), follicle-stimulating hormone(FSH)\\>40IU\u002FL or postmenopausal estradiol level \\\u003C5ng\u002FdL, or\n    * Have a history of bilateral oophorectomy, or\n    * Have a history of hysterectomy, or\n    * Have a history of bilateral salpingectomy\n20. Subjects who participated in other clinical trials within 3 months before the screening period;\n21. .Subjects who are allergic to tizanidine hydrochloride or tizanidine hydrochloride excipients;\n22. Subjects who cannot maintain their original diet and living habits during the trial;\n23. Subjects who intend to take estrogen and\u002For progesterone drugs during the screening period or after enrollment;\n24. Subject is a researcher involved in the study or an immediate family member (parent, spouse, sibling or child).",{"count":421,"type":22},189,[423],"PHASE3","In this study,189 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and\u002For migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults.",[30,31],[27,30,31],"2024-07-30",{"date":429,"type":51},"2024-08-01",{"date":431,"type":51},"2023-06-01",{"date":433,"type":22},"2025-12-25",{"name":435,"class":58},"Second Affiliated Hospital, School of Medicine, Zhejiang University",6,""]