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

NCT05262517

TerminatedPhase 3

Sponsor: Pfizer

Conditions: Temporomandibular Disorders (TMD)

Interventions: Rimegepant, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (32)

Phoenix, Arizona, United States
Phoenix, Arizona, United States
Hollywood, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Springfield, Missouri, United States
Springfield, Missouri, United States
Commack, New York, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Springboro, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Lake Jackson, Texas, United States
Lake Jackson, Texas, United States
Lampasas, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
+ 2 more on CT.gov