Status:
COMPLETED
Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Lead Sponsor:
Pfizer
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4-72 hours if untreated
- 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
- Sex and Reproductive Status:
- 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
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test at screening or prior to study drug administration
- Prohibited Medications:
- Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
- 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.
- 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.
- Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
- Subjects taking a prohibited medication as defined per protocol
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
1415 Patients enrolled
Trial Details
Trial ID
NCT05217927
Start Date
March 4 2022
End Date
December 11 2024
Last Update
December 16 2025
Active Locations (107)
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1
AMR Clinical
Tempe, Arizona, United States, 85281
2
Axiom Research, Llc
Colton, California, United States, 92324
3
Clinical Research Institute
Los Angeles, California, United States, 90048
4
Wr-Pri, Llc
Newport Beach, California, United States, 92660