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)

FacilityCityStateZIP
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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