Your session is about to expire
← Back to Search
Rimegepant for TMJ disorder
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 hours post-dose
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 moreSide effects data
From 2023 Phase 4 trial • 580 Patients • NCT051274862%
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
~12660
Find a Location
Who is running the clinical trial?
Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
37,461 Total Patients Enrolled
Biohaven Pharmaceutical Holding Company Ltd.Industry Sponsor
8 Previous Clinical Trials
14,308 Total Patients Enrolled
PfizerLead Sponsor
4,649 Previous Clinical Trials
17,744,250 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger