Brief Summary
The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.
Brief Title
Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Eligibility Criteria
Inclusion Criteria:
1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
Exclusion Criteria:
1. Sex and Reproductive Status:
1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
2. Women who are pregnant or breastfeeding
3. Women with a positive pregnancy test at screening or prior to study drug administration
2. Prohibited Medications:
1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
5. Subjects taking a prohibited medication as defined per protocol
1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
Exclusion Criteria:
1. Sex and Reproductive Status:
1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
2. Women who are pregnant or breastfeeding
3. Women with a positive pregnancy test at screening or prior to study drug administration
2. Prohibited Medications:
1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
5. Subjects taking a prohibited medication as defined per protocol
Inclusion Criteria
Inclusion Criteria:
1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
Gender
All
Gender Based
false
Keywords
Migraine
Episodic Migraine
Adult Migraine
Calcitonin Gene-related Peptide
Migraine Prevention
Migraine Prophylaxis
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05217927
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
BHV3000-404
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Primary Outcomes
Outcome Description
Change from baseline in mean number of migraine days per month
Outcome Measure
Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)
Outcome Time Frame
3 months (12 weeks)
Secondary Ids
Secondary Id
C4951010
Secondary Id
2021-005239-22
Secondary Id
2021-005239-22
Secondary Outcomes
Outcome Description
Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase
Outcome Time Frame
3 months (12 weeks)
Outcome Measure
Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).
Outcome Description
Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.
Outcome Time Frame
Weeks 9 to 12
Outcome Measure
Mean change from the Observation Phase.
Outcome Description
number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.
Outcome Time Frame
Weeks 1 to 4
Outcome Measure
Mean change from the Observation Phase
Outcome Description
Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.
Outcome Time Frame
Weeks 1 to 12
Outcome Measure
Mean number of acute migraine-specific medication days per month.
Outcome Description
Domain score of the Double-blind Treatment Phase.
Outcome Time Frame
At Week 12
Outcome Measure
Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.
Outcome Description
Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.
Outcome Time Frame
24 Weeks
Outcome Measure
Number and percentage of subjects with AEs by intensity.
Outcome Description
\>3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin \> 2x ULN during the Double-blind Treatment and Open-label Extension Phases.
Outcome Time Frame
24 Weeks
Outcome Measure
Number and percentage of subjects treated with rimegepant with AST or ALT elevations.
Outcome Description
By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.
Outcome Time Frame
24 Weeks
Outcome Measure
Number and percentage of subjects treated with rimegepant with hepatic-related AEs
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jelena Pavlovic
Investigator Email
jpavlovi@montefiore.org