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

Phase 3
Waitlist Available
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 hours post-dose
Awards & highlights
Pivotal Trial

Summary

This trial is testing rimegepant, a medication that may help relieve pain in people with Temporomandibular Disorders (TMD). TMD affects the jaw joint and surrounding muscles, causing pain and difficulty moving the jaw. Rimegepant works by blocking pain signals in the body, potentially offering relief for those who do not respond well to other treatments.

Eligible Conditions
  • TMJ disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
SPID From Baseline to 24-Hours Post-dose (SPID-24)
Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2)
Secondary study objectives
Change From Baseline in NRS Score at 2-Hours Post-Dose
Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose
Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose
+2 more

Side effects data

From 2023 Phase 4 trial • 580 Patients • NCT05127486
2%
Covid-19
2%
Nasopharyngitis
1%
Sinusitis
1%
Nausea
1%
Injection site pain
1%
Fatigue
1%
Migraine
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rimegepant
Galcanezumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV3000 (rimegepant)Experimental Treatment1 Intervention
One dose of rimegepant 75 mg ODT
Group II: Matching PlaceboPlacebo Group1 Intervention
One dose of matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2021
Completed Phase 4
~12920

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
37,475 Total Patients Enrolled
Biohaven Pharmaceutical Holding Company Ltd.Industry Sponsor
8 Previous Clinical Trials
14,281 Total Patients Enrolled
PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,798 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,800 Total Patients Enrolled
~35 spots leftby Dec 2025
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