Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

• Status: Not yet recruiting
• Trial end date: 2023-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biohaven Pharmaceuticals, Inc.
• Collaborator: Biohaven Pharmaceutical Holding Company Ltd.

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 3 months (12 weeks) prior to the Screening Visit.

5. Subjects taking a prohibited medication as defined per protocol