A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIpsen
About this trial
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers.
Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics.
This study aims to determine:
* The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of IPN10200 to inject at each point, * The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines.
Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has provided written informed consent and signed privacy/data protection documentation;
Male or female ≥18 to 80 years of age at the time of signing the informed consent;
Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
Diagnosis of migraine at ≤50 years of age;
Disqualifiers
History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua or new daily persistent headache;
Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.
Trial design
Design model
Parallel
Treatments tested in this trial
IPN10200
Biological/VaccineLyophilised powder
Placebo
Other interventionExcipients without active substance, Lyophilised powder
IPN10200 dose A
Biological/VaccineLyophilised powder
IPN10200 dose B
Biological/VaccineLyophilised powder
Treatment groups
641 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Step 1 - Cohort 1- IPN10200Experimental treatment 1 intervention
Group B: Step 1 - Cohort 1 - PlaceboPlacebo comparator 1 intervention
Group C: Step 1 - Cohort 2 - IPN10200Experimental treatment 1 intervention
Group D: Step 1 - Cohort 2 - PlaceboPlacebo comparator 1 intervention
Group E: Step 2- EM group IPN10200 Dose AExperimental treatment 1 intervention
Group F: Step 2- EM group IPN10200 Dose BExperimental treatment 1 intervention
Group G: Step 2- EM group placeboPlacebo comparator 1 intervention
Group H: Step 2- CM group IPN10200 Dose AExperimental treatment 1 intervention
Group I: Step 2- CM group IPN10200 Dose BExperimental treatment 1 intervention
Group J: Step 2- CM group placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
Time frame
For step 1: From baseline until end of study at Week 362
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
Time frame
For step 1: At all timepoints post injection until Week 363
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Time frame
For step 1: At all timepoints post injection until Week 364
Percentage of participants with clinically significant change from baseline in facial examination
Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Time frame
For step 1: At all timepoints post injection until Week 36Secondary outcomes
1
Change from baseline in the number of MMD
Time frame
For Step 1 and step 2: From Week 1 to Week 36.2
Change from baseline in the number of Monthly Headache Days (MHD)
Time frame
For Step 1 and step 2: From Week 1 to Week 363
Change from baseline in the number of moderate/severe MHD
Time frame
For Step 1 and step 2: From Week 1 to Week 364
Migraine prevention response
Migraine prevention response is assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥75% in MMD
Time frame
For Step 1 and step 2: From Week 1 to Week 36 Source ClinicalTrials.gov