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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pfizer
Study ID
NCT05518123
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
  • Placebo — DRUG
    Matching placebo with every other day dosing during DBT phase

Study Details

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

Key Dates

Start date
Nov 7, 2022
Status verified
Apr 2026
Primary completion
Mar 31, 2025
Completion
Jul 8, 2025

Study Design

Enrollment
962 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Rimegepant 75 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12) [ Time Frame: Observation phase (28 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12]) ]

Locations (23)

FacilityCityStateZIPSite coordinators
Clinical Research InstituteLos AngelesCalifornia90048-
California Neuroscience Research, LLCSherman OaksCalifornia91403-
Ki Health Partners LLC, dba New England Institute for Clinical ResearchStamfordConnecticut06905-
Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research UnitEdgewaterFlorida32132-
Wr-Msra,LlcLake CityFlorida32055-
AppleMed Research Group, LLCMiamiFlorida33126-
Sensible Healthcare LLCOcoeeFlorida34761-
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research UnitOrmond BeachFlorida32174-
Boston Clinical TrialsBostonMassachusetts02131-
Community Clinical Research Network, Inc.MarlboroughMassachusetts01752-
Michigan Headache & Neurological InstituteAnn ArborMichigan48104-
Rochester Medical GroupRochester HillsMichigan48307-
Clinvest Research, LLCSpringfieldMissouri65807-
St Charles Clinical ResearchWeldon SpringMissouri63304-
Wr-Crcn, LlcLas VegasNevada89118-
Albuquerque Clinical Trials. Inc.AlbuquerqueNew Mexico87102-
DiGiovanna Institute for Medical Education And ResearchNorth MassapequaNew York11758-
Headache Wellness Center, PCGreensboroNorth Carolina27405-
Synexus Clinical Research US, Inc. - AndersonAndersonSouth Carolina29621-
Alliance for Multispecialty Reseach, LLCKnoxvilleTennessee37909-
Red Star Research, LLCLake JacksonTexas77566-
DM Clinical ResearchTomballTexas77375-
Northwest Clinical Research CenterBellevueWashington98007-

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By condition
Migraine
By specialty
Neurology
By research site
Clinical Research Institute· Los Angeles, CACalifornia Neuroscience Research, LLC· Sherman Oaks, CAKi Health Partners LLC, dba New England Institute for Clinical Research· Stamford, CTSandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit· Edgewater, FLWr-Msra,Llc· Lake City, FLAppleMed Research Group, LLC· Miami, FL

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