Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pfizer
Study ID
NCT05509400
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rimegepant — DRUG
    DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
  • Placebo — DRUG
    DB Phase: matching placebo
  • Rimegepant — DRUG
    OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines

Study Details

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

Key Dates

Start date
Oct 18, 2022
Status verified
Apr 2026
Primary completion
Mar 10, 2025
Completion
Jun 10, 2025

Study Design

Enrollment
813 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Rimegepant
    Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
  • Placebo Comparator: Placebo
    Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine

Primary Outcome Measure

Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase [ Time Frame: At 2 hours post-dose ]

Locations (23)

FacilityCityStateZIPSite coordinators
Clinical Research InstituteLos AngelesCalifornia90048-
Ki Health Partners LLC, dba New England Institute for Clinical ResearchStamfordConnecticut06905-
Wr-Msra, LlcLake CityFlorida32055-
Sensible Healthcare LLCOcoeeFlorida34761-
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research UnitOrmond BeachFlorida32174-
WR-Mount Vernon Clinical Research, LLCSandy SpringsGeorgia30328-
Collective Medical ResearchOverland ParkKansas66210-
DelRicht ResearchNew OrleansLouisiana70115-
Boston Clinical TrialsBostonMassachusetts02131-
Community Clinical Research Network IncMarlboroughMassachusetts01752-
Michigan Headache & Neurological InstituteAnn ArborMichigan48104-
Rochester Medical GroupRochester HillsMichigan48307-
DM Clinical Research - DetroitSouthfieldMichigan48076-
Clinvest Research, LLCSpringfieldMissouri65807-
St Charles Clinical ResearchWeldon SpringMissouri63304-
DM Clinical Research - NY, NYBrooklynNew York11220-
New York Neurology AssociatesNew YorkNew York10003-
Montefiore Medical CenterThe BronxNew York10461-
Headache Wellness Center, PCGreensboroNorth Carolina27405-
Synexus Clinical Research US, Inc. - AndersonAndersonSouth Carolina29621-
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, CAKi Health Partners LLC, dba New England Institute for Clinical Research· Stamford, CTWr-Msra, Llc· Lake City, FLSensible Healthcare LLC· Ocoee, FLSandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit· Ormond Beach, FLWR-Mount Vernon Clinical Research, LLC· Sandy Springs, GA

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