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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Temporomandibular Disorders (TMD)

Treatments: Drug: Rimegepant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05262517

BHV3000-317

C4951016 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

BHV3000 (rimegepant)

Experimental group

Description:

One dose of rimegepant 75 mg ODT

Treatment:

Drug: Rimegepant

Matching Placebo

Placebo Comparator group

Description:

One dose of matching placebo

Treatment:

Drug: Placebo