A Phase II Study of NB001 for Acute Migraine Treatment
ConditionMigraine
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese PLA General Hospital
About this trial
The goal of this observational study is to Evaluate the Efficacy and Safety of NB001 for the Acute Treatment of Migraine in Adult patients diagnosed with migraine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient is aged ≥18 and ≤65 years at the Screening Visit, of either sex.
The patient has a diagnosis of migraine with aura or migraine without aura as defined by the ICHD-3 criteria confirmed at the Screening Visit.
The patient has had an onset of migraine at <50 years of age, with a history of migraine (with or without aura) of at least 1 year prior to the Screening Visit.
According to the investigator's judgment, the patient has had 2 to 8 moderate or severe migraine attacks per month in the 3 months prior to the Screening Visit.
Disqualifiers
The patient has a severe allergic constitution, or has known or suspected allergies to the investigational product or its excipients as judged by the investigator.
The patient is unable to distinguish migraine attacks from tension-type headaches or other headaches.
The patient has an average history of ≥15 headache days per month in the 3 months prior to the Screening Visit, or currently meets the ICHD-3 diagnostic criteria for chronic migraine, as judged by the investigator.
The patient has special types of migraine, such as hemiplegic migraine or migraine with brainstem aura.
Trial design
Design model
Parallel
Treatments tested in this trial
One tablet of NB001 plus three tablets of placebo
DrugTake 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine.
Two tablets of NB001 plus two tablets of placebo
DrugTake 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine.
Four tablets of NB001
DrugTake 4 tablets of NB001 at the onset of moderate-to-severe acute migraine.
Four tablets of placebo
DrugTake 4 tablets of placebo at the onset of moderate-to-severe acute migraine.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: One tablet of NB001 plus three tablets of placeboExperimental treatment 1 intervention
Group B: Two tablets of NB001 plus two tablets of placeboExperimental treatment 1 intervention
Group C: Four tablets of NB001Experimental treatment 1 intervention
Group D: Four tablets of placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
1.Proportion of subjects with no pain at 2 hours post-dose; 2.proportion of subjects with no most bothersome symptom (MBS) at 2 hours post-dose.
Time frame
2 hours post-doseSecondary outcomes
1
Proportion of Subjects with Pain Relief from Baseline at 2 Hours Post-Dose
Proportion of subjects with pain relief (defined as reduction from moderate/severe migraine-like headache at baseline \[pre-dose\] to mild headache or no headache) at 2 hours post-dose.
Time frame
2 hours post-dose2
Restoration of Normal Function at 2 Hours
Proportion of subjects with restoration of normal function (as reported by the Functional Disability Scale) at 2 hours post-dose.
Time frame
2 hours post-dose.3
Proportion of subjects using rescue medication within 24 hours post-dose.
Proportion of subjects using rescue medication within 24 hours post-dose.
Time frame
Within 24 hours post-dose.4
Proportion of subjects with sustained pain relief between 2 and 24 Hours Post-Dose
Proportion of subjects with sustained pain relief (defined as pain relief at 2 hours post-dose, no use of rescue medication, and no moderate/severe headache between 2 and 24 hours) between 2 and 24 hours post-dose.
Time frame
Between 2 and 24 hours post-dose.Other outcomes
1
Proportion with pain free at each post-dose time points.
Proportion of subjects with pain free at all recorded time points after dosing;
Time frame
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose2
Proportion with pain relief at each post-dose time points.
Proportion with pain relief at each post-dose time points.
Time frame
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose3
Proportion with absence of MBS at each post-dose time points.
Proportion of subjects with no MBS (migraine-associated symptoms) at each post-dose time points.
Time frame
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose4
Proportion of subjects with restoration of normal function at all post-dose time points.
Proportion of subjects with restoration of normal function at all post-dose time points.
Time frame
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-doseLocations
Sponsors and contacts
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Chinese PLA General Hospital
Lead sponsor
Hebei Provincial People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Nanjing Brain Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
People's Hospital of Wuhan University
Collaborator
The First Hospital of Jilin University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Peking Union Medical College Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
The Second Affiliated Hospital of Army Medical University
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
The Second Affiliated Hospital of the Air Force Medical University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Jiangsu Province Nanjing Brain Hospital
Collaborator
Source ClinicalTrials.gov
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