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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Temporomandibular Disorders (TMD)

In brief

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.

Key facts

Study ID

NCT05262517

Run by

Pfizer

People needed

126

Starts

2022-05-05

Expected to finish

2023-05-18

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bruce Nelson, DDS — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• The Medici Medical Research, LLC — Hollywood, Florida, United States
• The Medici Medical Research — Hollywood, Florida, United States
• SouthCoast Research Center, Inc — Miami, Florida, United States
• SouthCoast Research Center — Miami, Florida, United States
• Oceane7 Medical & Research Center, Inc. — Miami, Florida, United States
• Florida Craniofacial Institute — Tampa, Florida, United States
• Forcare Clinical Research — Tampa, Florida, United States
• Campus Health, Indiana University-Purdue University Indianapolis — Indianapolis, Indiana, United States
• IDS-IU Simon Cancer Center (IUSCC) — Indianapolis, Indiana, United States
• Indiana University School of Dentistry — Indianapolis, Indiana, United States
• University of Kentucky, College of Dentistry — Lexington, Kentucky, United States
• TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Clinvest Research, LLC — Springfield, Missouri, United States
• Clinvest Research — Springfield, Missouri, United States
• North Suffolk Neurology — Commack, New York, United States
• University of Rochester — Rochester, New York, United States
• Duke University — Raleigh, North Carolina, United States
• META Medical Research Institute,LLC. — Dayton, Ohio, United States
• Meta Medical Research — Dayton, Ohio, United States
• Kulkarni Orthodonties — Springboro, Ohio, United States
• Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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