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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: Rimegepant 75mg daily dosing; Drug: Rimegepant 75mg every other day dosing; Drug: Placebo comparator dosing

• Registration Number: NCT05217927
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Study Start: 2022-03-04
• Primary Completion: 2024-10-22
• Study Completion: 2024-12-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 698

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing	Rimegepant 75mg daily dosing	Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily
Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing	Rimegepant 75mg every other day dosing	Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Placebo comparator dosing	Placebo comparator dosing	Double-blind Treatment Phase: matching placebo dosed daily

Primary Outcome Measures

Name	Time	Method
Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)	3 months (12 weeks)	Change from baseline in mean number of migraine days per month

Secondary Outcome Measures

Name	Time	Method
Mean change from the Observation Phase	Weeks 1 to 4	number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.
Number and percentage of subjects treated with rimegepant with AST or ALT elevations.	24 Weeks	\>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.
Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.	At Week 12	Domain score of the Double-blind Treatment Phase.
Number and percentage of subjects with AEs by intensity.	24 Weeks	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.
Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).	3 months (12 weeks)	Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase
Mean change from the Observation Phase.	Weeks 9 to 12	Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.
Number and percentage of subjects treated with rimegepant with hepatic-related AEs	24 Weeks	By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.
Mean number of acute migraine-specific medication days per month.	Weeks 1 to 12	Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.

Trial Locations

Locations (105)

Alliance for Multispecialty Research, LLC; 🇺🇸 Las Vegas, Nevada, United States

Axiom Research, Llc; 🇺🇸 Colton, California, United States

Clinical Research Institute; 🇺🇸 Los Angeles, California, United States

Wr-Pri, Llc; 🇺🇸 Newport Beach, California, United States

California Neuroscience Research Medical Group, inc.; 🇺🇸 Sherman Oaks, California, United States

Neurology Offices of South Florida, PLLC; 🇺🇸 Boca Raton, Florida, United States

AppleMed Research Group, LLC; 🇺🇸 Miami, Florida, United States

Clinical Investigation Specialists, Inc.; 🇺🇸 Gurnee, Illinois, United States

MediSphere Medical Research Center, LLC; 🇺🇸 Evansville, Indiana, United States

Collective Medical Research; 🇺🇸 Overland Park, Kansas, United States

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