Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Pfizer
Study ID
NCT05262517
Phase
PHASE3
Status
Terminated

Conditions

  • Temporomandibular Disorders (TMD)

Eligibility Criteria

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

Interventions

  • Rimegepant — DRUG
    75 mg ODT
  • Placebo — DRUG
    matching placebo

Study Details

The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of Temporomandibular Disorders (TMD), which are medical conditions involving the temporomandibular joint (the joint connecting the jawbone to the skull) and surrounding muscles and tissues.

Key Dates

Start date
May 5, 2022
Status verified
Apr 2024
Primary completion
May 18, 2023
Completion
May 18, 2023

Study Design

Enrollment
126 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BHV3000 (rimegepant)
    One dose of rimegepant 75 mg ODT
  • Placebo Comparator: Matching Placebo
    One dose of matching placebo

Primary Outcome Measure

Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2) [ Time Frame: Baseline (0 hours) to 2-hours post-dose ]

Locations (32)

FacilityCityStateZIPSite coordinators
Arizona Research CenterPhoenixArizona85053-
Bruce Nelson, DDSPhoenixArizona85020-
The Medici Medical ResearchHollywoodFlorida33021-
The Medici Medical Research, LLCHollywoodFlorida33021-
Oceane7 Medical & Research Center, Inc.MiamiFlorida33144-
SouthCoast Research CenterMiamiFlorida33136-
SouthCoast Research Center, IncMiamiFlorida33136-
Florida Craniofacial InstituteTampaFlorida33607-
Forcare Clinical ResearchTampaFlorida33613-
Campus Health, Indiana University-Purdue University IndianapolisIndianapolisIndiana46202-
IDS-IU Simon Cancer Center (IUSCC)IndianapolisIndiana46202-
Indiana University School of DentistryIndianapolisIndiana46202-
University of Kentucky, College of DentistryLexingtonKentucky40536-
TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of MinnesotaMinneapolisMinnesota55455-
University of MinnesotaMinneapolisMinnesota55455-
Clinvest ResearchSpringfieldMissouri65810-
Clinvest Research, LLCSpringfieldMissouri65807-
North Suffolk NeurologyCommackNew York11725-
University of RochesterRochesterNew York14618-
Duke UniversityRaleighNorth Carolina27617-
Meta Medical ResearchDaytonOhio45432-
META Medical Research Institute,LLC.DaytonOhio45432-
Kulkarni OrthodontiesSpringboroOhio45066-
Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
University of PittsburghPittsburghPennsylvania15201-
Red Star ResearchLake JacksonTexas77566-
Red Star Research, LLCLake JacksonTexas77566-
FMC ScienceLampasasTexas76550-
JBRSalt Lake CityUtah84107-
JBR Clinical ResearchSalt Lake CityUtah84107-
Northwest Clinical Research CenterBellevueWashington98007-
Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian)SeattleWashington98121-

Find similar trials in Phoenix, AZ

By research site
Arizona Research Center· Phoenix, AZBruce Nelson, DDS· Phoenix, AZThe Medici Medical Research· Hollywood, FLThe Medici Medical Research, LLC· Hollywood, FLOceane7 Medical & Research Center, Inc.· Miami, FLSouthCoast Research Center· Miami, FL

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