Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders
- Conditions
- Temporomandibular Disorders (TMD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05262517
- Lead Sponsor
- Pfizer
- 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 temporomandibular joint (the joint connecting the jawbone to the skull) and surrounding muscles and tissues.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 126
* 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.
* 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching Placebo Placebo One dose of matching placebo BHV3000 (rimegepant) Rimegepant One dose of rimegepant 75 mg ODT
- Primary Outcome Measures
Name Time Method Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2) Baseline (0 hours) to 2-hours post-dose The SPID-2 was calculated by multiplying the pain intensity difference (PID) score at each post-dose timepoint by the duration (in hours) since the preceding timepoint, then summing the values over the 2 hours. Participants indicated pain using e-diary at each timepoint (0, 15, 30, 45-, 60-, 90- and 120-minutes post-dose) on an NRS score ranging from 0 (no pain) to 10 (worst imaginable pain). PID: calculated by finding the difference between the NRS score at each timepoint from the baseline NRS score (PID range is -6 \[best\] to 4 \[worst\]). Assuming a baseline pain intensity score of 6, possible score range of SPID-2 was: -12 (best) to 8 (worst). Lower SPID-2 score = more improvement from pain. SPID-2 Best is 2 hours\*-6 = -12 (assuming 0 pain intensity score \[pain-free\] for each timepoint) and 2) Worst is 2 hours\*4 = 8 (assuming 10 pain intensity score \[worst imaginable pain\] for each timepoint).
SPID From Baseline to 24-Hours Post-dose (SPID-24) Baseline (0 hours) to 24-hours post-dose The SPID-24 was calculated by multiplying the PID score at each post-dose timepoint by the duration (in hours) since the preceding timepoint, then summing the values over the 24 hours. Participants indicated pain using e-diary at each timepoint (0, 15, 30, 45, 60, 90 and 120 minutes and 4-, 8-, and 24-hours post-dose) on an NRS score ranging from 0 (no pain) to 10 (worst imaginable pain). PID: calculated by finding the difference between the NRS score at each timepoint from the baseline NRS score (PID range is -6 \[best\] to 4 \[worst\]). Assuming a baseline pain intensity score of 6, possible score range of SPID-24 was: -144 (Best) to 96 (worst). Lower SPID-24 score = more improvement from pain. SPID-24 best and worst scores were calculated as: 1) Best is 24 hours\* -6 = -144 (assuming 0 pain intensity score for each timepoint) and 2) Worst is 24 hours\*4 = 96 (assuming 10 pain intensity score for each timepoint).
- Secondary Outcome Measures
Name Time Method Time to Onset of Meaningful Pain Relief Baseline (0 hours) up to 24 hours post-dose Time to onset of meaningful pain relief post-dose is defined as the first nominal timepoint at which a 30% reduction of pain from baseline on NRS is achieved. TMD pain was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no pain" and 10 being "worst imaginable pain." Kaplan-Meier method was used for analysis.
Time to Onset of Initial Pain Relief Baseline (0 hour) to 24 hours post-dose Time to onset of initial pain relief post-dose is defined as the first nominal timepoint at which a 1-point reduction of pain from baseline on NRS is achieved. TMD pain was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no pain" and 10 being "worst imaginable pain." Kaplan-Meier method was used for analysis.
Change From Baseline in NRS Score at 2-Hours Post-Dose Baseline (0 hours), 2-hours post-dose TMD pain was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no pain" and 10 being "worst imaginable pain."
Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose Baseline (0 hour) to 2-hours post-dose Pain freedom was defined as an NRS score of zero at 2 hours post-dose (yes or no). TMD pain was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no pain" and 10 being "worst imaginable pain."
Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose Through 24 hours post-dose Rescue medications included any non-study medication recorded on the rescue medication case report form (CRF) with complete medication dates, and either (1) medication date/time is after the study drug start date/time if the medication time and study drug start time are both not missing, or (2) medication date is on or after study drug start date if the medication time or study drug start time is missing.
Trial Locations
- Locations (32)
The Medici Medical Research, LLC
🇺🇸Hollywood, Florida, United States
The Medici Medical Research
🇺🇸Hollywood, Florida, United States
Clinvest Research, LLC
🇺🇸Springfield, Missouri, United States
Clinvest Research
🇺🇸Springfield, Missouri, United States
North Suffolk Neurology
🇺🇸Commack, New York, United States
Kulkarni Orthodonties
🇺🇸Springboro, Ohio, United States
Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Red Star Research, LLC
🇺🇸Lake Jackson, Texas, United States
Red Star Research
🇺🇸Lake Jackson, Texas, United States
FMC Science
🇺🇸Lampasas, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, 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
Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian)
🇺🇸Seattle, Washington, United States
IDS-IU Simon Cancer Center (IUSCC)
🇺🇸Indianapolis, Indiana, United States
Indiana University School of Dentistry
🇺🇸Indianapolis, Indiana, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, 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
Duke University
🇺🇸Raleigh, North Carolina, United States
Campus Health, Indiana University-Purdue University Indianapolis
🇺🇸Indianapolis, Indiana, United States
Florida Craniofacial Institute
🇺🇸Tampa, Florida, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Forcare Clinical Research
🇺🇸Tampa, Florida, United States
Bruce Nelson, DDS
🇺🇸Phoenix, Arizona, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
JBR
🇺🇸Salt Lake City, Utah, United States
University of Kentucky, College of Dentistry
🇺🇸Lexington, Kentucky, United States
University of Rochester
🇺🇸Rochester, New York, United States
META Medical Research Institute,LLC.
🇺🇸Dayton, Ohio, United States
Meta Medical Research
🇺🇸Dayton, Ohio, United States