Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

Part of paid clinical trials in Fort Smith, Arkansas.

Sponsor
Pfizer
Study ID
NCT05156398
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Rimegepant 75mg or 50mg (2 X 25mg) ODT
  • Placebo — DRUG
    Matching placebo 75mg or 50mg (2 X 25mg) ODT

Study Details

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

Key Dates

Start date
Feb 28, 2022
Status verified
Jun 2026
Primary completion
Nov 29, 2031
Completion
Nov 27, 2032

Study Design

Enrollment
640 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Rimegepant / BHV3000
    Rimegepant 75mg or 50mg (2 X 25mg) ODT
  • Placebo Comparator: Matching Placebo
    Matching placebo 75mg or 50mg (2 X 25mg) ODT

Primary Outcome Measure

Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine [ Time Frame: 3 months (12 weeks) ]

Central Contacts

Locations (54)

FacilityCityStateZIPSite coordinators
The Belinga ClinicFort SmithArkansas72901-
Advanced Investigative Medicine, Inc.HawthorneCalifornia90250-
Velocity Clinical Research San DiegoLa MesaCalifornia91942-
Colorado Springs Neurological AssociatesColorado SpringsColorado80907-
Advanced Neurosciences Research, LLCFort CollinsColorado80528-
Meridian Clinical Research, LLCWashington D.C.District of Columbia20016-
Velocity Clinical Research, Washington DCWashington D.C.District of Columbia20016-
Accel Research Sites Network - Edgewater Clinical Research UnitEdgewaterFlorida32132-
Direct Helpers Research CenterHialeahFlorida33012-
New Med Research, IncHollywoodFlorida33020-
Complete Health ResearchOrmond BeachFlorida32174-
D&H Tamarac Research Center LLCTamaracFlorida33321-
Santos Research Center, CORPTampaFlorida33615-
Augusta UniversityAugustaGeorgia30912-
WR-Mount Vernon Clinical Research, LLCSandy SpringsGeorgia30328-
Meridian Clinical Research, LLCSavannahGeorgia31406-
Extraordinary Family HealthcareSnellvilleGeorgia30078-
Renew Health Clinical Research LLCSnellvilleGeorgia30078-
Northwest Clinical Trials, Inc.BoiseIdaho83704-
Diamond Headache ClinicChicagoIllinois60642-
Nola Research Works, LLCNew OrleansLouisiana70125-
Safe Haven Clinical ResearchClintonMississippi39056-
Roy Blunt NextGen Precision Health BuildingColumbiaMissouri65211-
University of MissouriColumbiaMissouri65212-
University of Missouri Health Care - Investigation PharmacyColumbiaMissouri65212-
University of Missouri-Clinical and Translational Sciences UnitColumbiaMissouri65212-
Velocity Clinical Research, Grand IslandGrand IslandNebraska68803-
Papillion Research Center/CCT ResearchPapillionNebraska68046-
Renown Regional Medical CenterRenoNevada89502-
Dent Neurosciences Research Center, Inc.AmherstNew York14226-
Montefiore Medical CenterThe BronxNew York10461-
Carolina Institute for Clinical Research, LLCFayettevilleNorth Carolina28303-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Velocity Clinical ResearchCincinnatiOhio45242-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Coastal Pediatric ResearchCharlestonSouth Carolina29414-
Tribe Clinical Research LLCGreenvilleSouth Carolina29607-
Avera McKennan Hospital & University Health CenterSioux FallsSouth Dakota57105-
Avera Medical Group Pediatrics - Dawley FarmSioux FallsSouth Dakota57110-
Avera Research InstituteSioux FallsSouth Dakota57108-
Monroe Carell Jr Children's Hospital at VanderbiltNashvilleTennessee37232-
Alina Clinical Trials, LLC.DallasTexas75209-
North Texas Center for Clinical ResearchFriscoTexas75034-
DM Clinical Research - Cy FairHoustonTexas77065-
NeuroCare PlusHoustonTexas77094-
SCLA Management - Drop BoxHoustonTexas77077-
SCLA Management OfficeHoustonTexas77077-
Red Star Research, LLCLake JacksonTexas77566-
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical TrialsMcAllenTexas78503-
DCT-Stone Oak, LLC dba Discovery Clinical TrialsSan AntonioTexas78258-
Texas Institute for Neurological DisordersShermanTexas75092-
DM Clinical Research (Administrative Office Only)TomballTexas77375-
Victoria Clinical Research GroupVictoriaTexas77901-
Meridian Clinical Research, LLCPortsmouthVirginia23703-

Find similar trials in Fort Smith, AR

By condition
Migraine
By specialty
Neurology
By research site
The Belinga Clinic· Fort Smith, ARAdvanced Investigative Medicine, Inc.· Hawthorne, CAVelocity Clinical Research San Diego· La Mesa, CAColorado Springs Neurological Associates· Colorado Springs, COAdvanced Neurosciences Research, LLC· Fort Collins, COMeridian Clinical Research, LLC· Washington D.C., DC

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