Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Rimegepant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 962
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Sippy Downs, Queensland, Australia, 4556
      • USC Clinical Trials Sunshine Coast
• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt Am Worthersee
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University Innsbruck
• Belgium
  • Antwerp, Belgium, 2610
    • GZA Ziekenhuizen
  • Bruges, Belgium, 8000
    • AZ Sint-Jan Brugge-Oostende AV
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
  • Liège, Belgium, 4000
    • Clinique de la Citadelle
  • Saint Nicolas Province de Liège, Belgium, 4420
    • Cabinet Privé Dr. Simona Sava
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • UZ Brussel
• Canada
  • Québec, Canada, G2J 0C4
    • Alpha Recherche Clinique
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Brampton, Ontario, Canada, L6V 1C2
      • NeuPath Centre for Pain and Spine
  • Quebec
    • Lévis, Quebec, Canada, G6W0M5
      • Centre de Recherche Saint-Louis/Clinique Neuro-Levis
    • Québec, Quebec, Canada, G3K 2P8
      • Alpha Recherche Clinique
• Denmark
  • Esbjerg, Denmark, DK-6700
    • University Hospital of Southern Denmark
  • Viborg, Denmark, DK-8800
    • Hospitalsenhed Midt
  • Capital Region
    • Copenhagen NV, Capital Region, Denmark, 2400
      • Bispebjerg Hospital
    • Glostrup Municipality, Capital Region, Denmark, 2600
      • Danish Headache Center
• Finland
  • Tampere, Finland, 33100
    • Terveystalo Tampere
  • Turku, Finland, 20100
    • Terveystalo Pulssi
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00180
      • Terveystalo Ruoholahti
• Germany
  • Berlin, Germany, 12672
    • Synexus - Prüfzentrum Berlin
  • Ulm Baden-Wuerttemberg, Germany, 89073
    • Neuropoint GmbH
  • Baden-Wurttemberg
    • Göppingen, Baden-Wurttemberg, Germany, 73033
      • Schmerz- und Palliativzentrum Göppingen
  • Hesse
    • Bad Homburg, Hesse, Germany, 61350
      • Zentrum für klinische Forschung
    • Frankfurt am Main, Hesse, Germany, 65929
      • Kopfschmerzzentrum Frankfurt
    • Frankfurt am Main, Hesse, Germany, 60313
      • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
    • Wiesbaden, Hesse, Germany, 65189
      • Intermed GmbH
  • Lower Saxony
    • Westerstede, Lower Saxony, Germany, 26655
      • Studienzentrum Nordwest
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Synexus - Prüfzentrum Leipzig
• Italy
  • Florence, Italy, 50134
    • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
  • Milan, Italy, 20133
    • IRCCS Fondazione Besta
  • Modena, Italy, 41124
    • University Modena e Reggio Emilia
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
  • MI
    • Milan, MI, Italy, 20132
      • IRCCS Ospedale San Raffaele
  • Naples
    • Naples, Naples, Italy, 80134
      • AOU Luigi Vanvitelli
  • Rome/lazio
    • Rome, Rome/lazio, Italy, 00163
      • IRCCS San Raffaele
• Mexico
  • Aguascalientes, Mexico, 20116
    • Centro de Investigación Médica de Aguascalientes (CIMA)
  • Mexico City, Mexico, CDMX 06700
    • Clinstile, SA de CV
  • Mexico City, Mexico, CP 14050
    • Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
  • State of Mexico
    • Cuautitlán Izcalli, State of Mexico, Mexico, 54769
      • Phylasis Clinicas Research S. de R.L. de C.V.
    • Tlalnepantla, State of Mexico, Mexico, C.P. 54055
      • Clinical Research Institute S.C.
  • Yucatán
    • Mérida, Yucatán, Mexico, CP. 97070
      • Medical Care and Research S.A. de C.V.
• Poland
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice
  • Szczecin, Poland, 70-784
    • MICS Centrum Medyczne Szczecin
  • Warsaw, Poland, 02-172
    • MTZ Clinical Research Powered by PRATIA
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 50-414
    • Premium Clinic Wrocław
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-163
      • Centrum Medyczne NEUROMED
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
      • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • Lubusz Voivodeship
    • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
      • Twoja Przychodnia Nowosolskie Centrum Medyczne
  • Malopolska
    • Krakow, Malopolska, Poland, 31-530
      • CenterMed Kraków Sp. z o.o.
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-773
      • Concept Medica
    • Warsaw, Masovian Voivodeship, Poland, 02-739
      • MICS Centrum Medyczne Damiana Walbrzyska
    • Warsaw, Masovian Voivodeship, Poland, 01-018
      • Dr Sękowska Leczenie Bólu
  • Małopolska
    • Oświęcim, Małopolska, Poland, 32-600
      • Instytut Zdrowia
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 91-363
      • Centrum Leczenia Bolu dr n med Lukasz Kmieciak
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08006
    • Hospital Clinic de Barcelona Plato Headquarters
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Salamanca, Spain, 28006
    • Hospital Universitario Ruber Juan Bravo
  • Santander, Spain, 39008
    • University Hospital Marqués de Valdecilla
  • Seville, Spain, 41013
    • Virgen del Rocío University Hospital
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario
  • Valladolid, Spain, 47010
    • Hospital Clínico Universitario de Valladolid
  • Alicante
    • Elda, Alicante, Spain, 03600
      • Hospital Universitario de Elda
• Sweden
  • Gothenburg, Sweden, 40545
    • Carlanderska Hospital
  • Lund, Sweden, 222 22
    • Skåneuro Privatmottagning
  • Stockholm, Sweden, 112 39
    • Hälsoklustret
  • Stockholm, Sweden, 117 27
    • Akardo Med Site
  • Uppsala, Sweden, 75185
    • University Hospital Uppsala (VO Neuro)
  • Stockholms LÄN [se-01]
    • Solna, Stockholms LÄN [se-01], Sweden, 171 64
      • CTC Solna
  • Uppsala LÄN [se-03]
    • Uppsala, Uppsala LÄN [se-03], Sweden, 752 37
      • CTC MTC
• United Kingdom
  • Bristol, United Kingdom, BS32 4SY
    • Cognition Health - Bristol
  • London, United Kingdom, SE5 9PJ
    • Kings college london
  • Swinton, United Kingdom, M27 8FF
    • 4 Medical Clinical Solutions
  • Birmingham
    • Edgebaston, Birmingham, United Kingdom, B16 8LT
      • Re: Cognition Health Ltd.
  • EAST Riding
    • Hull, EAST Riding, United Kingdom, HU3 2JZ
      • Hull University Hospitals NHS Trust
  • Essex
    • Ilford, Essex, United Kingdom, IG1 4HP
      • 4 Medical Clinical Solutions London
  • Norfolk
    • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
      • James Paget University Hospitals NHS Foundation Trust
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN17 2UR
      • Lakeside Healthcare Group Research
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Clinical Research Institute
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research, LLC
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners LLC, dba New England Institute for Clinical Research
  • Florida
    • Edgewater, Florida, United States, 32132
      • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
    • Lake City, Florida, United States, 32055
      • Wr-Msra,Llc
    • Miami, Florida, United States, 33126
      • AppleMed Research Group, LLC
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare LLC
    • Ormond Beach, Florida, United States, 32174
      • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Marlborough, Massachusetts, United States, 01752
      • Community Clinical Research Network, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache & Neurological Institute
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Medical Group
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research, LLC
    • Weldon Spring, Missouri, United States, 63304
      • St Charles Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Wr-Crcn, Llc
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials. Inc.
  • New York
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education and Research
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center, PC
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc. - Anderson
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty Reseach, LLC
  • Texas
    • Lake Jackson, Texas, United States, 77566
      • Red Star Research, LLC
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
3. 4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
5. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).

Exclusion Criteria:

1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
2. Current medication overuse headaches.
3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]).
6. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo with every other day dosing during DBT phase
Experimental: Rimegepant 75 mg	Drug: Rimegepant; Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase

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 the Entire DBT Phase (Weeks 1 to 12)	A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.	Observation phase (28 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 >= 50 Percent (%) Reduction From OP in the Number of Moderate or Severe Migraine Days (MD) Per Month Over the Entire DBT Phase (Weeks 1 to 12)	Moderate or severe MD: a MD of moderate or severe headache pain intensity. MD: any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. Qualified migraine headache: migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of moderate or severe MD per month were prorated to 28 days and derived from data in the on-DBT efficacy analysis period as follows: 28*(total number of moderate or severe MD 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 First 4 Weeks (Weeks 1 to 4) of the DBT Phase	A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.	Observation phase (28 days prior to randomization), Week 1 to Week 4 of the DBT phase
Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase	A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.	Observation phase (28 days prior to randomization), Week 9 to Week 12 of the DBT phase
Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase	MSQ version 2.1 was a self-administered, 14-item instrument validated in 3 domains: role function-restrictive (7 items), role function-preventive (4 items), emotional function (3 items). The restrictive role function domain consisted of 7 items that described how migraine limited one's daily social and work-related activities. Each item was scored on 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) and Week 12 of the DBT phase
Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Week 12 of the DBT Phase	MIBS was a 4-item self-administered questionnaire that measures: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Each item was rated on a 6-point scale as: don't know/ not applicable; never; rarely; some of the time; much of the time; most or all of the time. The MIBS score was the weighted sum of the item scores and ranged from 0 to 12. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.	Baseline (Day 1) and Week 12
Number of Participants With Any Adverse Events (AEs) by Worst Intensity 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. AE intensity included mild, moderate and severe, where Mild: usually transient and required only minimal treatment or therapeutic intervention. Event did not generally interfere with usual activities of daily living. Moderate: usually alleviated with additional specific therapeutic intervention. Event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to participant. Severe: interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Participants were counted once in each intensity category based on greatest intensity of unique adverse event preferred terms.	DBT Phase: From Day 1 to Week 12
Number of Participants With Any AEs by Worst Intensity 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. AE intensity included mild, moderate and severe, where Mild: usually transient and required only minimal treatment or therapeutic intervention. Event did not generally interfere with usual activities of daily living. Moderate: usually alleviated with additional specific therapeutic intervention. Event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to participant. Severe: interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Participants were counted once in each intensity category based on greatest intensity of unique adverse event preferred terms.	OLE Phase: From Week 12 to Week 24
Number of Participants With Serious AEs (SAEs) in the DBT Phase	A serious adverse event (SAE) was any event that met any of the following criteria at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the offspring who received rimegepant and other important medical events.	DBT Phase: From Day 1 to Week 12
Number of Participants With SAEs in the OLE Phase	A SAE was any event that met any of the following criteria at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the offspring who received rimegepant and other important medical events.	OLE Phase: From Week 12 to Week 24
Number of Participants With 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. In this outcome measure, participants with AEs leading to discontinuation of study drug were reported.	DBT Phase: From Day 1 to Week 12
Number of Participants With 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. In this outcome measure, participants with AEs leading to discontinuation of study drug were reported.	OLE Phase: From Week 12 to Week 24
Number of Participants With Grade 3 to 4 Laboratory Abnormalities: DBT Phase	Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. Only those Grade 3 or 4 laboratory tests with non-zero values in any of treatment arms are reported in this outcome measure.	DBT Phase: From Day 1 to Week 12
Number of Participants With Grade 3 to 4 Laboratory Abnormalities: OLE Phase	Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to NCI CTCAE v5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. Only those Grade 3 or 4 laboratory tests with non-zero values in any of treatment arms are reported in this outcome measure.	OLE Phase: From Week 12 to Week 24
Percentage of Participants With >= 50% Reduction From OP in the Number of Migraine Days Per Month (Regardless of Pain Intensity) Over the Entire DBT Phase (Weeks 1 to 12)	A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days and derived from data in the 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 Number of Acute Migraine-Specific Medication Days Per Month in Each Month and Over the Entire DBT Phase (Weeks 1 to 12)	An acute migraine-specific medication day was defined as any calendar day during which a participant took a migraine-specific acute migraine medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. The number of acute migraine-specific medication days per month were prorated to 28 days.	DBT phase Months 1, 2 and 3; overall DBT through Month 3 (Week 1 to 12)
Mean Change From Baseline in MIBS Scores at Weeks 4, 8, and 12 in the DBT Phase	MIBS was a 4-item self-administered questionnaire that measures: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Each item was rated on a 6-point scale as: don't know/ not applicable; never; rarely; some of the time; much of the time; most or all of the time. The MIBS score was the weighted sum of the item scores and ranged from 0 to 12. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.	DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Mean Change From Baseline in MSQ Domain Scores at Weeks 4, 8, and 12 in the DBT Phase	MSQ was a self-administered, 14-item instrument validated in 3 domains: role function-restrictive (7 items), role function-preventive (4 items), emotional function (3 items). Each item was scored on 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 domain scores are computed as a sum of item responses and rescaled to a 0 to 100 scale such that lower score (0) indicated poor quality of life and higher scores (100) indicated better quality of life.	DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Mean Change From Baseline in Migraine Functional Impact Questionnaire (MFIQ) Domain Scores in Each Month of the DBT Phase	MFIQ was a 26-item participant-report questionnaire. It is designed to measure the subjective impact of migraine on physical, social, and emotional functioning over 5 domains: physical function (5 items), usual activities (10 items), social function (5 items), emotional function (5 items) and overall impact on usual activities (16 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days.	DBT Phase: Baseline (Day 1), Months 1, 2, and 3
Change From Baseline in Work Productivity and Activity Impairment (WPAI) - Migraine Absenteeism Scores at Weeks 4, 8, and 12 in the DBT Phase	The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The absenteeism score was calculated from Q2 and Q4 for participants who responded "yes" to Q1 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.	DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Change From Baseline in WPAI - Migraine Presenteeism Scores at Weeks 4, 8, and 12 in the DBT Phase	The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The presenteeism score was calculated using Q5 for participants who responded "yes" to Q1 and had Q4>0 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.	DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Change From Baseline in WPAI - Migraine Work Productivity Loss Scores at Weeks 4, 8, and 12 in the DBT Phase	The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The work productivity loss score was calculated using Q2, Q4, and Q5 for participants who responded "yes" to Q1 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.	DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Change From Baseline in WPAI - Migraine Activity Impairment Scores at Weeks 4, 8, and 12 in the DBT Phase	The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The activity impairment score was calculated using Q6 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.	DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Mean Change From Baseline in Patient Global Assessment (PGA) Score in Each Month of the DBT Phase	The PGA scale was a single item assessment that measured the participant's overall assessment of migraine on a 5-point scale as: (1) very good: asymptomatic and no limitation of normal activities; (2) good: mild symptoms and no limitation of normal activities; (3) fair: moderate symptoms and limitation of some normal activities; (4) poor: severe symptoms and inability to carry out most normal activities; (5) very poor: very severe symptoms which are intolerable and inability to carry out all normal activities. Lower scores indicated fewer symptoms and less disability to carry out normal activities.	DBT Phase: Baseline (Day 1), Months 1, 2, and 3

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Pozo-Rosich P, Gien Lopez JA, Lisewski P, Aslan AN, Seehra H, Thiry A, Abraham L, Ramirez LM, Fountaine R, Fullerton T. Does rimegepant prevent migraine attacks in people who have not found other treatments taken by mouth (orally) to work well? A plain language summary of clinical study findings. Pain Manag. 2026 Apr 28:1-12. doi: 10.1080/17581869.2026.2646702. Online ahead of print.
• Pozo-Rosich P, Lopez JAG, Lisewski P, Aslan AN, Seehra H, Thiry A, Abraham L, Ramirez LM, Fountaine R, Fullerton T. A phase 4, randomized, double-blind, placebo-controlled trial evaluating the efficacy and tolerability of rimegepant for the prevention of episodic migraine in adults with a history of inadequate response to traditional oral preventive medications. Cephalalgia. 2025 Nov;45(11):3331024251391378. doi: 10.1177/03331024251391378. Epub 2025 Nov 18.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): July 8, 2025

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Headache; Migraine Prevention; Headache Prevention; Migraine Prevention in adults with inadequate response to oral preventative medications
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; rimegepant sulfate
• Other Study ID Numbers: BHV3000-407 (CTIS (EU)); C4951012 (Other Identifier: Alias Study Number); 2024-513270-21-00 (Registry Identifier: 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