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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Placebo comparator dosing; Drug: Rimegepant 75mg every other day dosing; Drug: Rimegepant 75mg daily dosing

Study type: Interventional

Funder types: Industry

Identifiers

NCT05217927

C4951010 (Other Identifier)

BHV3000-404

2021-005239-22 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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1,415 participants in 3 patient groups, including a placebo group

Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing

Experimental group

Description:

Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily

Treatment:

Drug: Rimegepant 75mg daily dosing

Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing

Experimental group

Description:

Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo

Treatment:

Drug: Rimegepant 75mg every other day dosing

Placebo comparator dosing

Placebo Comparator group

Description:

Double-blind Treatment Phase: matching placebo dosed daily

Treatment:

Drug: Placebo comparator dosing