Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Episodic Migraine, Adult Migraine, Calcitonin Gene-related Peptide, Migraine Prevention, Migraine Prophylaxis
Eligibility Criteria
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:
- 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
Exclusion Criteria:
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 3 months (12 weeks) prior to the Screening Visit.
- Subjects taking a prohibited medication as defined per protocol
Sites / Locations
- Alliance for Multispecialty Research, LLCRecruiting
- Axiom Research, LlcRecruiting
- Clinical Research InstituteRecruiting
- Wr-Pri, LlcRecruiting
- California Neuroscience Research Medical Group, inc.Recruiting
- Neurology Offices of South Florida, PLLCRecruiting
- AppleMed Research Group, LLCRecruiting
- Clinical Investigation Specialists, Inc.Recruiting
- MediSphere Medical Research Center, LLCRecruiting
- Collective Medical ResearchRecruiting
- Collective Medical ResearchRecruiting
- Clinvest Research, LLCRecruiting
- Alliance for Multispecialty Research, LLCRecruiting
- Dent Neurosciences Research Center, Inc.Recruiting
- Montefiore Medical CenterRecruiting
- Upstate Clinical Research Associates, LLCRecruiting
- Wellnow Urgent Care and ResearchRecruiting
- Wellnow Urgent Care and ResearchRecruiting
- WellNow Urgent Care and ResearchRecruiting
- WellNow Urgent Care and ResearchRecruiting
- Wellnow Urgent Care and ResearchRecruiting
- Velocity Clinical Research, MedfordRecruiting
- Preferred Primary Care Physicians, Inc.Recruiting
- Velocity Clinical Research - ProvidenceRecruiting
- Velocity Clinical Research - ColumbiaRecruiting
- Velocity Clinical Research, GaffneyRecruiting
- Tribe Clinical Research LLCRecruiting
- Clinical Research Associates, Inc.Recruiting
- FutureSearch Trials of NeurologyRecruiting
- FutureSearch Trials of Dallas, LPRecruiting
- Texas Center for Drug Development, Inc.Recruiting
- APD Clinical ResearchRecruiting
- Wasatch Clinical Research , LLC(Administrative Location)Recruiting
- Seattle Clinical Research CenterRecruiting
- Medizinische Universitat InnsbruckRecruiting
- Christian-Doppler-KlinikRecruiting
- Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK)
- Calgary Headache & Assessment Management Program (CHAMP)
- OCT Research ULCRecruiting
- James K. Lai MD Inc.Recruiting
- Centricity ResearchRecruiting
- True North Clinical Research Inc.Recruiting
- Aggarwal and Associates LimitedRecruiting
- Manna Research Inc. (Burlington North)Recruiting
- Milestone Research Inc.Recruiting
- Bluewater Clinical Research Group Inc.Recruiting
- Mirtorabi Medicine Professional CorporationRecruiting
- Toronto Memory ProgramRecruiting
- Manna Research (Toronto)Recruiting
- Diex Recherche Sherbrooke Inc.Recruiting
- Hopital Gabriel MontpiedRecruiting
- Hopital Roger Salengro CHU LilleRecruiting
- Hopital de La TimoneRecruiting
- Centre Hospitalier Annecy GenevoisRecruiting
- Klinische Forschung Karlsruhe GmbHRecruiting
- Vitos Orthopaedische Klinik KasselRecruiting
- Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-WestRecruiting
- Siteworks - Zentrum fur klinische Studien HannoverRecruiting
- Klinische Forschung Schwerin GmbHRecruiting
- Universitatsklinikum Jena
- Klinische Forschung Berlin-Mitte
- Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location
- Studienzentrum Dr. A Schwittay
- Klinische Forschung Dresden GmbH
- Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen
- Kopfschmerzzentrum FrankfurtRecruiting
- Klinische Forschung Hamburg GmbHRecruiting
- Zentrum für klinische Studien HannoverRecruiting
- Klinische Forschung Karlsruhe GmbHRecruiting
- Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
- Datamed GmbHRecruiting
- NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth KrankenhausRecruiting
- Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern
- Klinische Forschung Schwerin GmbHRecruiting
- Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang SchwarzRecruiting
- AOU Careggi - Centro CefaleeRecruiting
- Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
- Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia
- IRCCS Istituto delle Scienze Neurologiche Bologna
- ASST Spedali Civili di Brescia, U.O. Neurologia
- Neurorehabilitation Unit-ICOT Istituto Marco Pasquali
- IRCCS San Raffaele Roma
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-DworakRecruiting
- Centrum Medyczne Pratia BydgoszczRecruiting
- Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-SzerejRecruiting
- Krakowska Akademia Neurologii Sp. Z o.o.Recruiting
- Krakowska Akademia Neurologil Sp. Z o.o.Recruiting
- Next Stage Sp. Z o.o.Recruiting
- Wojskowy Instytut MedycznyRecruiting
- Pratia MCM KrakowRecruiting
- Centrum Medyczne Pratia CzestochowaRecruiting
- Centrum Medyczne Pratia KatowiceRecruiting
- NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSISRecruiting
- Solumed Centrum MedyczneRecruiting
- NZOZ Neuromed M. i M. Nastaj Sp. P.Recruiting
- MTZ Clinical Research Powered by Pratia
- Hospital Clinico Universitario de Valladolid • HCUVRecruiting
- Hospital Alvaro Cunqueiro
- Instituto de Investigaciones del Sueno
- Hospital Universitario La PazRecruiting
- Virgen del Rocio HospitalRecruiting
- Ladulaas Clinical TrialsRecruiting
- PharmasiteRecruiting
- CTC Clinical Trial Consultants AB
- ProbarE i LundRecruiting
- PharmasiteRecruiting
- Studieenheten Akademiskt Specialistcentrum SLSO
- Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation TrustRecruiting
- Panthera BiopartnersRecruiting
- Re:Cognition Health - WinchesterRecruiting
- Intelligent ClinicalRecruiting
- Panthera Bio PartnersRecruiting
- Re:Cognition Health - LondonRecruiting
- Re:Cognition Health-Private PracticeRecruiting
- CPS ResearchRecruiting
- Re-Cognition Health - BristolRecruiting
- Panthera Biopartners - SheffieldRecruiting
- Re-Cognition HealthRecruiting
- Re-Cognition HealthRecruiting
- Panthera Biopartners GlasgowRecruiting
- Panthera Biopartners - EnfieldRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing
Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Placebo comparator dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Double-blind Treatment Phase: matching placebo dosed daily