Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders
Summary
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.
Timeline
- Start
- 2022-05-05
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
Outcome
Missed primary endpoint
Stopped (Business): “Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.”
registry analysis (other test); Rimegepant (BHV3000) vs Placebo; Least square (LS) mean difference -0.15 (95% CI -1.78 to 1.48) NCT05262517 ↗
registry analysis (other test); Rimegepant (BHV3000) vs Placebo; LS mean difference 5.12 (95% CI -21.35 to 31.59) NCT05262517 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Oral |