migraine headaches with or without aura MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Vydura
Product Name: Rimegepant sulfate
Product Code: BHV-3000
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Rimegepant
CAS Number: 1374024-48-2
Current Sponsor code: BHV
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Target Population: Minimum 1 year documented history of migraines (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition.3 Per self-report, with confirmation from Investigator / supporting medical record, subjects must have: a. Migraine attacks present for more than 1 year from the Screening Visit b. Age of onset prior to 50 years of age c. Migraine attacks lasting about 4–72 hours, if untreated d. 4 to 14 migraine days, on average, across the 3 months prior to the Screening Visit e. 4 to 14 migraine days during the 28-day Observation Phase f. Subjects must be able to distinguish migraine attacks from tension headaches g. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication) 2) Age and Reproductive Status: a) Subjects =18 years-old b) Subject meets reproductive criteria. Refer to Section 16.6 c) At the Baseline Visit, prior to dispensing investigational study drug, WOCBP must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before dosing with study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 570 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Target Disease Exclusion a) History of cluster headaches, basilar migraine (with aura), or hemiplegic migraine b) Current medication overuse headaches c) 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28-day Observation Phase d) 7 or more non-migraine headache days per month, on-average, across the 3-months prior to the Screening Visit or during the 28-day Observation Phase e) Inadequate response to agents across > 4 categories of recognized, orally administered, migraine-preventive medications 2. Medical History and Current Diseases: a) History of gastric or small intestinal surgery or disease or conditions that causes malabsorption b) BMI = 35kg/m2 c) Alcohol or drug abuse within the past 12 months or subjects with any significant substance use disorder within the past 12 months from the date of the Screening Visit d) Current diagnosis of major depressive disorder requiring treatment with an atypical antipsychotic e) Current diagnosis of schizophrenia, bipolar disorder, or borderline personality disorder f) Other major psychiatric disorder that might interfere with the ability to properly report clinical outcomes g) Major depressive disorder or any anxiety disorder which requires more than 1 daily medication for each disorder. h) Major depressive episode within last 12 months prior to the Screening Visit. i) Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5 within the last 12 months prior to the Screening Visit, OR subjects who endorse any of the 5 C-SSRS Suicidal Behavior Items within the last 10 years prior to the Screening Visit, OR subjects who present a serious risk of suicide j) Active chronic pain syndromes k) Other pain syndromes (including trigeminal neuralgia), dementia, significant neurological disorders other than migraine l) Current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease m) Myocardial infarction, acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack within 6 months prior to the Screening Visit n) Uncontrolled hypertension (high blood pressure). o) Any unstable medical conditions (e.g., history of congenital heart disease, arrhythmia, or cancer) p) Positive drug screen for drugs of abuse that in the Investigator’s judgment is medically significant, in that it would impact the safety of the subject or the interpretation of the study results. 3. Allergies and Adverse Drug Reactions: History of drug or other allergy which, in the opinion of the investigator, makes the subject unsuitable for participation in the study. 4. Sex and Reproductive Status WOCBP who are unwilling or unable to use required contraception a) Women who are pregnant or breastfeeding b) Women with a positive pregnancy test at Screening Visit 5. ECG and Laboratory Test Findings - as specified in the protocol. 6. Prohibited Medications and Devices a) Recognized migraine-preventive medication taken within 30 days prior the Screening (with exceptions) b) Non-Narcotic Analgesics or paracetamol taken 15 days per month during the 3 months prior to the Screening Visit c) Any device for migraine prevention or treatment within 3 months prior to the Screening Visit d) Ergotamine taken 10 days per month on a regular basis for 3 months in the year prior to the Screening Visit e) Narcotic, such as opioid or barbiturate taken for 4 days per month duri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of rimegepant to placebo as an EOD dosing regimen for prophylaxis in adults with a history of inadequate response to agents across 2-4 categories of recognized, orally-administered migraine preventive medications as measured by the mean reduction from the Observation Phase in the number of migraine days per month (28 days) over the entire DBT Phase.;Secondary Objective: Key Secondary Objectives: 1. To compare the proportion of subjects with = 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12) between rimegepant and placebo. 2. To compare the mean reduction from the Observation Phase in the number of migraine days per month in the first 4 weeks of the DBT Phase between rimegepant and placebo. 3. To compare the mean reduction from the Observation Phase in the number of migraine days per month in the last 4 weeks of the DBT Phase between rimegepant and placebo. 4. To compare the mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ) restrictive role function domain score at Week 12 of the DBT Phase between rimegepant and placebo. 5. To compare the mean change from baseline in Migraine Interictal Burden Scale (MIBS) score at Week 12 of the DBT Phase between rimegepant and placebo. ;Primary end point(s): Mean change from the Observation Phase in the number of migraine days per month over the entire double-blind treatment (DBT) Phase.;Timepoint(s) of evaluation of this end point: Weeks 1 to 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints 1.Proportion of subjects with = 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12). 2.Mean change from the Observation Phase in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase. 3.Mean change from the Observation Phase in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase. 4.Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the DBT Phase. 5.Mean change from baseline in the MIBS score at Week 12 of the DBT Phase. Other Secondary Endpoints: 1.Number and percentage of subjects with AEs by intensity, SAEs, AEs leading to study drug discontinuation, and Grade 3 to 4 laboratory test abnormalities on treatment during the DBT and OLE Phases. 2.Proportion of subjects with = 50% reduction from the Observation Phase in the number of migraine days (regardless of headache pain intensity) per month over the entire DBT Phase (Weeks 1 to 12). 3.Mean number of acute migraine-specific medication days per month in each month and over the entire DBT Phase (Weeks 1 to 12). 4.Mean change from baseline in MIBS scores at Weeks 4, 8, and 12 in the DBT Phase. 5.Mean change from baseline in the MSQ domain scores (restrictive role function domain, preventive role function domain, and emotional function domain) at Weeks 4, 8, and 12 in the DBT Phase. 6.Mean change from baseline in the MFIQ scores (Physical Function, Usual Activities, Overall impact on Usual Activities, Social Function, and Emotional Function) in each month of the DBT Phase. 7.Mean change from baseline in the WPAI – Migraine scores (absenteeism, presenteeism, work productivity loss and activity impairment) at Weeks 4, 8, and 12 in the DBT Phase. 8.Mean change from baseline in the PGA score in each month of the DBT Phase.;Timepoint(s) of evaluat | — |
Countries
Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, Germany, Italy, Mexico, Poland, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed