Status:
TERMINATED
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders
Lead Sponsor:
Pfizer
Conditions:
Temporomandibular Disorders (TMD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tem...
Eligibility Criteria
Inclusion
- \* 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
- \* 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.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05262517
Start Date
May 5 2022
End Date
May 18 2023
Last Update
May 16 2024
Active Locations (32)
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1
Bruce Nelson, DDS
Phoenix, Arizona, United States, 85020
2
Arizona Research Center
Phoenix, Arizona, United States, 85053
3
The Medici Medical Research, LLC
Hollywood, Florida, United States, 33021
4
The Medici Medical Research
Hollywood, Florida, United States, 33021