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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Temporomandibular Disorders (TMD)

Conditions
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Temporomandibular Disorders (TMD)

Intervention / Treatment
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* Drug: Rimegepant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: * Subject has a minimum 3-month to a maximum 5-year history of temporomandibular disorder diagnosed by a healthcare provider. At least one instance of pain ≥ 6 on a Numeric Rating Scale (NRS) (0-10) in the jaw and/or temple area on either side in the past 30 days prior to the Screening Visit. Subject agrees to study-required restrictions of new pain medication, injection therapy, oral devices, occlusal splint therapy or any other pain management techniques during the course of the study. Subject agrees to study-required birth control methods during the course of the study and female subjects must not be breastfeeding. No clinically significant abnormality identified on the medical or laboratory evaluation. Exclusion Criteria: * Subject has an exclusionary headache, joint, pain, connective tissue, or developmental disorder. Subject has an exclusionary history of trauma, surgery, or radiation treatment to the head and neck. Body Mass Index ≥ 33kg/m2. Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions. Subjects taking/using excluded therapies. Participation in clinical trial with non-biological investigational agents or investigational interventional treatments. Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study. Planned participation in any other investigational clinical trial while participating in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BHV3000 (rimegepant)<br>One dose of rimegepant 75 mg ODT | Drug: Rimegepant<br>* 75 mg ODT<br>* Other names: BHV3000;|
| Placebo Comparator: Matching Placebo<br>One dose of matching placebo | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of Temporomandibular Disorders | Assessed by calculating the Sum of Pain Intensity Difference (SPID-2) derived by using the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) | First 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate rimegepant compared to placebo on the weighted Sum of Pain Intensity Difference (SPID-24) | Assessed by calculating the Sum of Pain Intensity Difference (SPID-24) derived by using the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) | First 24 hours post-dose | 
| To evaluate rimegepant compared to placebo on change from baseline of pain | Assessed on the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) | 2 hours post-dose | 
| To evaluate rimegepant compared to placebo on the proportion of subjects that are pain free | Assessed using the number of evaluable subjects that report no pain measured on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) | 2 hours post-dose | 
| To evaluate rimegepant compared to placebo on time to onset of meaningful pain relief | Assessed by the first nominal timepoint at which the pain on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) decreases by 30% | Number of minutes post dose in which pain decreases by 30% | 
| To evaluate rimegepant compared to placebo on time to onset of initial pain relief | Assessed by the first nominal timepoint at which the pain on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) decreases by 1 point | Number of minutes post dose in which pain decreased by 1 point | 
| To evaluate rimegepant compared to placebo on the probability of requiring rescue medication | Assessed using the number of subjects that take rescue medication | Within 24 hours of initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular Disorders, TMD, Temporomandibular Joint, TMJ