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

A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Rimegepant 75mg daily dosing; Drug: Rimegepant 75mg every other day dosing; Drug: Placebo comparator dosing

• Study Type: Interventional
• Enrollment (Actual): 1415
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Christian-Doppler-Klinik
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medizinische Universität Innsbruck
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3M 1M4
      • Calgary Headache & Assessment Management Program (CHAMP)
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • OCT Research ULC
    • Vancouver, British Columbia, Canada, V5Z 1K3
      • James K. Lai MD Inc.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S 1N2
      • Centricity Research
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Burlington, Ontario, Canada, L7M 4Y1
      • Manna Research Inc. (Burlington North)
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research Inc.
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
    • Stouffville, Ontario, Canada, L4A 1H2
      • Mirtorabi Medicine Professional Corporation
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research (Toronto)
  • Quebec
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke Inc.
• France
  • Clermont-Ferrand, France, 63003
    • Hôpital Gabriel Montpied
  • Marseille, France, 13385
    • Hopital De La Timone
• Germany
  • Böhlen, Germany, 04564
    • Studienzentrum Dr. A Schwittay
  • Cologne, Germany, 50935
    • Datamed GmbH
  • Frankfurt, Germany, 65929
    • Kopfschmerzzentrum Frankfurt
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Kiel, Germany, 24194
    • Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
  • Baden-Wurttemberg
    • Karlsruhe, Baden-Wurttemberg, Germany, 76137
      • Klinische Forschung Karlsruhe GmbH
  • Hesse
    • Kassel, Hesse, Germany, 34131
      • Vitos Orthopaedische Klinik Kassel
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30449
      • Siteworks - Zentrum fur klinische Studien Hannover
    • Westerstede, Lower Saxony, Germany, 26655
      • Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Klinische Forschung Schwerin GmbH
  • Saxony
    • Dresden, Saxony, Germany, 01069
      • Klinische Forschung Dresden GmbH
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Universitatsklinikum Jena
• Italy
  • Bologna, Italy, 40139
    • IRCCS Istituto delle Scienze Neurologiche Bologna, Unità Operativa di Neurologia - Ospedale Bellaria
  • Brescia, Italy, 25123
    • ASST Spedali Civili di Brescia, U.O. Neurologia
  • Latina, Italy, 04100
    • Neurorehabilitation Unit-ICOT Istituto Marco Pasquali
  • Milan, Italy, 20133
    • Istituto Neurologico "Carlo Besta" Fondazione IRCCS
  • Rome, Italy, 00197
    • IRCCS San Raffaele Roma
  • Lazio
    • Rome, Lazio, Italy, 00189
      • Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza
  • Padua
    • Pavia, Padua, Italy, 27100
      • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche
• Poland
  • Lublin, Poland, 20-064
    • NZOZ Neuromed M. i M. Nastaj Sp. P.
  • Warsaw, Poland, 02-172
    • MTZ Clinical Research Powered by Pratia
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-529
      • Solumed Centrum Medyczne
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Centrum Medyczne Pratia Bydgoszcz
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-510
      • Pratia MCM Krakow
    • Krakow, Lesser Poland Voivodeship, Poland, 31-505
      • Krakowska Akademia Neurologii Sp. z o.o.
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
      • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-582
      • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 04-141
      • Wojskowy Instytut Medyczny
    • Warsaw, Masovian Voivodeship, Poland, 02-121
      • Next Stage Sp. Z o.o.
  • Silesian Voivodeship
    • Częstochowa, Silesian Voivodeship, Poland, 42-200
      • Centrum Medyczne Pratia Czestochowa
    • Katowice, Silesian Voivodeship, Poland, 40-081
      • Centrum Medyczne Pratia Katowice
    • Katowice, Silesian Voivodeship, Poland, 40-123
      • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
    • Katowice, Silesian Voivodeship, Poland, 40-689
      • Neurologia Slaska Centrum Medyczne
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28036
    • Instituto de Investigaciones del Sueño
  • Seville, Spain, 41013
    • Virgen del Rocio Hospital
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Neurology Service: Hospital Universitario Marques de Valdecilla
  • Castille and León
    • Valladolid, Castille and León, Spain, 47003
      • Hospital Clinico Universitario de Valladolid • HCUV
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Hospital Álvaro Cunqueiro
• Sweden
  • Borås, Sweden, SE 506 30
    • Ladulaas Clinical Trials
  • Lund, Sweden, 222 22
    • ProbarE i Lund
  • Stockholm, Sweden, 113 29
    • ProbarE i Stockholm AB
  • Stockholm, Sweden, 11361
    • Studieenheten Akademiskt Specialistcentrum SLSO
  • Skåne County
    • Malmo, Skåne County, Sweden, 21152
      • PharmaSite
  • Stockholms LÄN [se-01]
    • Stockholm, Stockholms LÄN [se-01], Sweden, 171 64
      • CTC Clinical Trial Consultants AB
• United Kingdom
  • Glasgow, United Kingdom, G51 4TY
    • Panthera Biopartners Glasgow
  • London, United Kingdom, EN3 4GS
    • Panthera Biopartners - Enfield
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S40 4AA
      • Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust
  • Great Manchester
    • Rochdale, Great Manchester, United Kingdom, O11 4AU
      • Panthera Biopartners
  • Hampshire
    • Winchester, Hampshire, United Kingdom, SO21 1HU
      • Re:Cognition Health - Winchester
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9QB
      • Panthera Bio Partners
  • Marylebone
    • London, Marylebone, United Kingdom, W1G 9JF
      • Re:Cognition Health - London
    • London, Marylebone, United Kingdom, W1G9RU
      • Re:Cognition Health-Private Practice
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN17 2UR
      • Lakeside Healthcare Research
  • Scotland
    • Glasgow, Scotland, United Kingdom, G20 7BE
      • CPS Research
  • South WEST
    • Bristol, South WEST, United Kingdom, BS32 4SY
      • Re-Cognition Health - Bristol
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S2 5FX
      • Panthera Biopartners - Sheffield
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7YD
      • Re-Cognition Health
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B16 8LT
      • Re-Cognition Health
• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • AMR Clinical
  • California
    • Colton, California, United States, 92324
      • Axiom Research, LLC
    • Los Angeles, California, United States, 90048
      • Clinical Research Institute
    • Newport Beach, California, United States, 92660
      • Wr-Pri, Llc
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Neurology Offices of South Florida, PLLC
    • Miami, Florida, United States, 33126
      • AppleMed Research Group, LLC
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc.
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Collective Medical Research
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research, LLC
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center, Inc.
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates, LLC
  • Ohio
    • Columbus, Ohio, United States, 43228
      • Wellnow Urgent Care and Research
    • Huber Heights, Ohio, United States, 45424
      • Hometown Urgent Care and Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research - Providence
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Velocity Clinical Research - Columbia
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clinical Research, Gaffney
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Magnolia, Texas, United States, 77355
      • APD Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research , LLC(Administrative Location)
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing; 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; Daily
Experimental: Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing; Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo	Drug: Rimegepant 75mg every other day dosing; Every other day
Placebo Comparator: Placebo comparator dosing; Double-blind Treatment Phase: matching placebo dosed daily	Drug: Placebo comparator dosing; Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Percentage of participants with >= 50% reduction from OP, in number of migraine days (moderate or severe) in the overall DBT phase is reported in this outcome measure. 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]).	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	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 a month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28*(total number of migraine days in the month) / (total number of e-diary efficacy data in the month). Mean change in number of migraine days per month in the last 4 weeks of DBT phase as compared to OP phase was calculated and reported in this outcome measure.	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	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 a month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28*(total number of migraine days in the month / (total number of e-diary efficacy data in the month. Mean change in number of migraine days per month in the first 4 weeks of DBT phase as compared to OP phase was calculated and reported in this outcome measure.	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)	An acute migraine-specific medication day was defined as any calendar day during which the participant took a migraine-specific medication (i.e., triptan or ergotamine). The number of acute migraine-specific medication days per month were prorated to 28 days and derived for on-DBT efficacy analysis period as follows: 28*(total number of acute migraine-specific medication days through Month 3/ (total number of e-Diary efficacy data days through Month 3).	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	MSQoL is a self-administered, 14-item instrument validated in 3 domains: role restriction, role prevention, and the emotional function. The restrictive role function domain consisted of 7 items that described how migraine limited one's daily social and work-related activities. Participants were required to respond to items using a 6-point scale ranging from 1 to 6, where "1: none of the time," "2: a little bit of the time," "3: some of the time," "4: a good bit of the time," "5: most of the time," and "6: all of the time,". Item scores were recoded using (7 - original score). Raw dimension scores for restrictive role function domain were computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that lower score (0) indicated poor quality of life and higher scores (100) indicated better quality of life.	Baseline (Day 1), Week 12 of the DBT phase
Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AEs were categorized as mild: usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate: was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the participant. Severe: Interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. AEs included both non-SAEs and serious adverse events (SAEs).	DBT: From Week 1 to Week 20
Number of Participants With Mild, Moderate and Severe AEs OLE Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AEs were categorized as mild: usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate: was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the participant. Severe: Interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. AEs included both non-SAEs and SAEs.	OLE: From Week 12 to Week 32
Number of Participants With Serious Adverse Events (SAEs) in DBT Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of the participant who received rimegepant and other important medical events.	DBT: From Week 1 to Week 20
Number of Participants With SAEs in OLE Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of the participant who received rimegepant and other important medical events.	OLE: From Week 12 to Week 32
Number of Participants With AEs Leading to Study Drug Discontinuation in DBT Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. In this outcome measure, participants with adverse events leading to study drug discontinuation were reported.	DBT: From Week 1 to Week 12
Number of Participants With AEs Leading to Study Drug Discontinuation in OLE Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. In this outcome measure, participants with adverse events leading to study drug discontinuation were reported.	OLE: From Week 12 to Week 24
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase	The laboratory parameters were graded according to the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 and using division of AIDS (DAIDS) toxicity grading scale version 2.1 (glucose, low density lipoprotein [LDL] cholesterol, uric acid and urinalysis) and for other parameters (eosinophils, hemoglobin, leukocytes, albumin, lymphocytes, neutrophils, platelets, alanine aminotransferase, alkaline phosphatase ,aspartate aminotransferase, bicarbonate, bilirubin, calcium, cholesterol, creatine kinase, creatinine, lactate dehydrogenase, potassium, sodium, triglycerides) CTCAE version v5.0 was used. Severity were graded as Grade 1=mild AE, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants according to Grade 3 or 4 laboratory abnormalities are reported. Only laboratory abnormalities with non-zero values in any of the treatment arms are reported.	DBT: From Week 1 to Week 20
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase	The laboratory parameters were graded according to the NCI CTCAE version 5.0 and using DAIDS toxicity grading scale version 2.1 (glucose, LDL cholesterol, uric acid and urinalysis). And for other parameters (eosinophils, hemoglobin, leukocytes, albumin, lymphocytes, neutrophils, platelets, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, cholesterol, creatine kinase, creatinine, lactate dehydrogenase, potassium, sodium, triglycerides) CTCAE version v5.0 was used. Severity was graded as Grade 1=mild AE, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants according to Grade 3 or 4 laboratory abnormalities are reported. Only laboratory abnormalities with non-zero values in any of the treatment arms are reported.	OLE: From Week 12 to Week 32
Number of Participants With Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Elevations > 3* Upper Limit of Normal (ULN) Concurrent With (Total Bilirubin) TBL >2*ULN in DBT Phase	Number of participants with AST or ALT >3*ULN concurrent with TBL >2*ULN in DBT phase were reported in this outcome measure.	DBT: From Week 1 to Week 20
Number of Participants With AST or ALT Elevations > 3* ULN Concurrent With TBL >2*ULN in OLE Phase	Number of participants with AST or ALT >3*ULN concurrent with TBL >2*ULN in DBT phase were reported in this outcome measure.	OLE: From Week 12 to Week 32
Number of Participants With Hepatic-Related AEs in the DBT Phase	\An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic-related AEs included: alanine aminotransferase and aspartate aminotransferase increased, liver function test abnormal, liver function test increased, bilirubin conjugated increased, blood bilirubin increased, transaminases increased and hyperbilirubinemia. Number of participants with any hepatic-related AEs in the DBT phase were reported in this outcome measure.	DBT: From Week 1 to Week 20
Number of Participants With Hepatic-Related AEs in the OLE Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic AEs included: alanine aminotransferase and aspartate aminotransferase increased, liver function test abnormal, bilirubin conjugated, hepatic enzyme increased, blood bilirubin unconjugated increased, blood bilirubin and transaminases increased and hepatic function abnormal. Number of participants with any hepatic-related AEs in the OLE phase were reported in this outcome measure.	OLE: From Week 12 to Week 32
Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the DBT Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic-related AEs included: alanine aminotransferase and aspartate aminotransferase increased, liver function test and blood bilirubin increased. Number of participants with any hepatic-related AEs leading to study drug discontinuation is reported in this outcome measure.	DBT: From Week 1 to Week 12
Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the OLE Phase	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. Hepatic-related AEs included: aspartate aminotransferase increased and liver function test abnormal. Number of participants with any hepatic-related AEs leading to study drug discontinuation is reported in this outcome measure.	OLE: From Week 12 to Week 24

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Biohaven Pharmaceutical Holding Company Ltd.
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Migraine; Episodic Migraine; Adult Migraine; Calcitonin Gene-related Peptide; Migraine Prevention; Migraine Prophylaxis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; rimegepant sulfate
• Other Study ID Numbers: BHV3000-404; C4951010 (Other Identifier: Alias Study Number); 2021-005239-22 (EudraCT Number: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No