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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Pfizer
Study ID
NCT05217927
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Mar 4, 2022
Status verified
Oct 2025
Primary completion
Oct 22, 2024
Completion
Dec 11, 2024

Study Design

Enrollment
1,415 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • Placebo Comparator: Placebo comparator dosing
    Double-blind Treatment Phase: matching placebo dosed daily

Primary Outcome Measure

Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) [ Time Frame: Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12]) ]

Locations (30)

FacilityCityStateZIPSite coordinators
AMR ClinicalTempeArizona85281-
Axiom Research, LlcColtonCalifornia92324-
Clinical Research InstituteLos AngelesCalifornia90048-
Wr-Pri, LlcNewport BeachCalifornia92660-
California Neuroscience Research Medical Group, inc.Sherman OaksCalifornia91403-
Neurology Offices of South Florida, PLLCBoca RatonFlorida33428-
AppleMed Research Group, LLCMiamiFlorida33126-
Clinical Investigation Specialists, Inc.GurneeIllinois60031-
MediSphere Medical Research Center, LLCEvansvilleIndiana47714-
Collective Medical ResearchOverland ParkKansas66210-
Clinvest Research, LLCSpringfieldMissouri65807-
Alliance for Multispecialty Research, LLCLas VegasNevada89119-
Dent Neurosciences Research Center, Inc.AmherstNew York14226-
Montefiore Medical CenterThe BronxNew York10461-
Upstate Clinical Research Associates, LLCWilliamsvilleNew York14221-
Wellnow Urgent Care and ResearchColumbusOhio43228-
Hometown Urgent Care and ResearchHuber HeightsOhio45424-
Velocity Clinical Research, MedfordMedfordOregon97504-
Preferred Primary Care Physicians, Inc.PittsburghPennsylvania15236-
Velocity Clinical Research - ProvidenceEast GreenwichRhode Island02818-
Velocity Clinical Research - ColumbiaColumbiaSouth Carolina29204-
Velocity Clinical Research, GaffneyGaffneySouth Carolina29340-
Tribe Clinical Research LLCGreenvilleSouth Carolina29607-
Clinical Research Associates, Inc.NashvilleTennessee37203-
FutureSearch Trials of NeurologyAustinTexas78731-
FutureSearch Trials of Dallas, LPDallasTexas75231-
Texas Center for Drug Development, Inc.HoustonTexas77081-
APD Clinical ResearchMagnoliaTexas77355-
Wasatch Clinical Research , LLC(Administrative Location)Salt Lake CityUtah84107-
Seattle Clinical Research CenterSeattleWashington98105-

Related coverage on Hipa.ai

Find similar trials in Tempe, AZ

By condition
Migraine
By specialty
Neurology
By research site
AMR Clinical· Tempe, AZAxiom Research, Llc· Colton, CAClinical Research Institute· Los Angeles, CAWr-Pri, Llc· Newport Beach, CACalifornia Neuroscience Research Medical Group, inc.· Sherman Oaks, CANeurology Offices of South Florida, PLLC· Boca Raton, FL

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