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

NCT05217927 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: BHV3000-4042021-005239-22C4951010
• Study Type: interventional
• Target: 1,415
• Locations: 10 countries
• Sites: 107

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.

Conditions

Migraine

Keywords

Migraine; Episodic Migraine; Adult Migraine; Calcitonin Gene-related Peptide; Migraine Prevention; Migraine Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)

  A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for \>=30 minutes, and meeting either \>=2 of the pain features: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity OR \>=1 of the associated symptoms: nausea and/or vomiting; photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for a month in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days through Month 3 \[Weeks 1 to 12\]/ (total number of e-diary efficacy data days through Month 3 \[Weeks 1 to 12\]). Mean change in number of migraine days per month in DBT phase as compared to OP phase was calculated and reported in this outcome measure.

  Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])

Secondary Outcomes (19)

• Percentage of Participants With Greater Than Equal to (>=) 50 Percent (%) Reduction From OP in Number of Moderate to Severe Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)

  DBT phase (through Month 3 [Week 1 to 12])

• Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase

  Observation phase (from 31 days before randomization), Week 9 to Week 12 of the DBT phase

• Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase

  Observation phase (from 31 days before randomization), Week 1 to Week 4 of the DBT phase

• Mean Number of Acute Migraine-Specific Medication Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)

  DBT phase (through Month 3 [Week 1 to 12])

• Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase

  Baseline (Day 1), Week 12 of the DBT phase

Study Arms (3)

Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing

EXPERIMENTAL

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

Drug: Rimegepant 75mg daily dosing

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

EXPERIMENTAL

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

Drug: Rimegepant 75mg every other day dosing

Placebo comparator dosing

PLACEBO COMPARATOR

Double-blind Treatment Phase: matching placebo dosed daily

Drug: Placebo comparator dosing

Interventions

Rimegepant 75mg daily dosing DRUG

Daily

Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing

Rimegepant 75mg every other day dosing DRUG

Every other day

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

Placebo comparator dosing DRUG

Placebo comparator

Placebo comparator dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (107)

AMR Clinical

Tempe, Arizona, 85281, United States

Location

Axiom Research, Llc

Colton, California, 92324, United States

Location

Clinical Research Institute

Los Angeles, California, 90048, United States

Location

Wr-Pri, Llc

Newport Beach, California, 92660, United States

Location

California Neuroscience Research Medical Group, inc.

Sherman Oaks, California, 91403, United States

Location

Neurology Offices of South Florida, PLLC

Boca Raton, Florida, 33428, United States

Location

AppleMed Research Group, LLC

Miami, Florida, 33126, United States

Location

Clinical Investigation Specialists, Inc.

Gurnee, Illinois, 60031, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Collective Medical Research

Overland Park, Kansas, 66210, United States

Location

Clinvest Research, LLC

Springfield, Missouri, 65807, United States

Location

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, 89119, United States

Location

Dent Neurosciences Research Center, Inc.

Amherst, New York, 14226, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

Wellnow Urgent Care and Research

Columbus, Ohio, 43228, United States

Location

Hometown Urgent Care and Research

Huber Heights, Ohio, 45424, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, 15236, United States

Location

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research - Columbia

Columbia, South Carolina, 29204, United States

Location

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, 29340, United States

Location

Tribe Clinical Research LLC

Greenville, South Carolina, 29607, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

APD Clinical Research

Magnolia, Texas, 77355, United States

Location

Wasatch Clinical Research , LLC(Administrative Location)

Salt Lake City, Utah, 84107, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

Medizinische Universitat Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Christian-Doppler-Klinik

Salzburg, 5020, Austria

Location

Calgary Headache & Assessment Management Program (CHAMP)

Calgary, Alberta, T3M 1M4, Canada

Location

OCT Research ULC

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

James K. Lai MD Inc.

Vancouver, British Columbia, V5Z 1K3, Canada

Location

Centricity Research

Halifax, Nova Scotia, B3S 1N2, Canada

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Manna Research Inc. (Burlington North)

Burlington, Ontario, L7M 4Y1, Canada

Location

Milestone Research Inc.

London, Ontario, N5W 6A2, Canada

Location

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, N7T 4X3, Canada

Location

Mirtorabi Medicine Professional Corporation

Stouffville, Ontario, L4A 1H2, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Manna Research (Toronto)

Toronto, Ontario, M9W 4L6, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Hopital de La Timone

Marseille, 13385, France

Location

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Baden-Wurttemberg, 76137, Germany

Location

Vitos Orthopaedische Klinik Kassel

Kassel, Hesse, 34131, Germany

Location

Siteworks - Zentrum fur klinische Studien Hannover

Hanover, Lower Saxony, 30449, Germany

Location

Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West

Westerstede, Lower Saxony, 26655, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 01069, Germany

Location

Universitatsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Studienzentrum Dr. A Schwittay

Böhlen, 04564, Germany

Location

Datamed GmbH

Cologne, 50935, Germany

Location

Kopfschmerzzentrum Frankfurt

Frankfurt, 65929, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Neurologisch-verhaltensmedizinische Schmerzklinik Kiel

Kiel, 24194, Germany

Location

Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza

Rome, Lazio, 00189, Italy

Location

Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

Pavia, Padua, 27100, Italy

Location

Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche

Florence, Tuscany, 50134, Italy

Location

IRCCS Istituto delle Scienze Neurologiche Bologna, Unità Operativa di Neurologia - Ospedale Bellaria

Bologna, 40139, Italy

Location

ASST Spedali Civili di Brescia, U.O. Neurologia

Brescia, 25123, Italy

Location

Neurorehabilitation Unit-ICOT Istituto Marco Pasquali

Latina, 04100, Italy

Location

Istituto Neurologico "Carlo Besta" Fondazione IRCCS

Milan, 20133, Italy

Location

IRCCS San Raffaele Roma

Rome, 00197, Italy

Location

Solumed Centrum Medyczne

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Krakowska Akademia Neurologii Sp. Z o.o.

Krakow, Lesser Poland Voivodeship, 31-505, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

Location

Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Next Stage Sp. Z o.o.

Warsaw, Masovian Voivodeship, 02-121, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, Masovian Voivodeship, 04-141, Poland

Location

Centrum Medyczne Pratia Czestochowa

Częstochowa, Silesian Voivodeship, 42-200, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, 40-081, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

Katowice, Silesian Voivodeship, 40-123, Poland

Location

Neurologia Slaska Centrum Medyczne

Katowice, Silesian Voivodeship, 40-689, Poland

Location

NZOZ Neuromed M. i M. Nastaj Sp. P.

Lublin, 20-064, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

Neurology Service: Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Clinico Universitario de Valladolid • HCUV

Valladolid, Castille and León, 47003, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Instituto de Investigaciones del Sueno

Madrid, 28036, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Virgen del Rocio Hospital

Seville, 41013, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Pharmasite

Malmo, Skåne County, 21152, Sweden

Location

CTC Clinical Trial Consultants AB

Stockholm, Stockholms LÄN [se-01], 171 64, Sweden

Location

Ladulaas Clinical Trials

Borås, SE 506 30, Sweden

Location

ProbarE i Lund

Lund, 222 22, Sweden

Location

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Location

Studieenheten Akademiskt Specialistcentrum SLSO

Stockholm, 11361, Sweden

Location

Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust

Chesterfield, Derbyshire, S40 4AA, United Kingdom

Location

Panthera Biopartners

Rochdale, Great Manchester, O11 4AU, United Kingdom

Location

Re:Cognition Health - Winchester

Winchester, Hampshire, SO21 1HU, United Kingdom

Location

Panthera Bio Partners

Preston, Lancashire, PR2 9QB, United Kingdom

Location

Re:Cognition Health - London

London, Marylebone, W1G 9JF, United Kingdom

Location

Re:Cognition Health-Private Practice

London, Marylebone, W1G9RU, United Kingdom

Location

Lakeside Healthcare Research

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

CPS Research

Glasgow, Scotland, G20 7BE, United Kingdom

Location

Re-Cognition Health - Bristol

Bristol, South WEST, BS32 4SY, United Kingdom

Location

Panthera Biopartners - Sheffield

Sheffield, South Yorkshire, S2 5FX, United Kingdom

Location

Re-Cognition Health

Guildford, Surrey, GU2 7YD, United Kingdom

Location

Re-Cognition Health

Birmingham, WEST Midlands, B16 8LT, United Kingdom

Location

Panthera Biopartners Glasgow

Glasgow, G51 4TY, United Kingdom

Location

Panthera Biopartners - Enfield

London, EN3 4GS, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: March 4, 2022
• Primary Completion: October 22, 2024
• Study Completion: December 11, 2024
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

FR (2); US (30); SE (6); GB (14); IT (8); PL (14); CA (12); AU (2); DE (12); ES (7)