Study Stopped
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Temporomandibular Disorders (TMD)
2 other identifiers
interventional
126
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2022
Shorter than P25 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2023
CompletedResults Posted
Study results publicly available
May 16, 2024
CompletedMay 16, 2024
April 1, 2024
1 year
February 21, 2022
April 12, 2024
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2)
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).
Baseline (0 hours) to 2-hours post-dose
SPID From Baseline to 24-Hours Post-dose (SPID-24)
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).
Baseline (0 hours) to 24-hours post-dose
Secondary Outcomes (5)
Change From Baseline in NRS Score at 2-Hours Post-Dose
Baseline (0 hours), 2-hours post-dose
Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose
Baseline (0 hour) to 2-hours post-dose
Time to Onset of Meaningful Pain Relief
Baseline (0 hours) up to 24 hours post-dose
Time to Onset of Initial Pain Relief
Baseline (0 hour) to 24 hours post-dose
Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose
Through 24 hours post-dose
Study Arms (2)
BHV3000 (rimegepant)
EXPERIMENTALOne dose of rimegepant 75 mg ODT
Matching Placebo
PLACEBO COMPARATOROne dose of matching placebo
Interventions
Eligibility Criteria
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:
- Body Mass Index ≥ 33kg/m2.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Bruce Nelson, DDS
Phoenix, Arizona, 85020, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
The Medici Medical Research, LLC
Hollywood, Florida, 33021, United States
The Medici Medical Research
Hollywood, Florida, 33021, United States
SouthCoast Research Center, Inc
Miami, Florida, 33136, United States
SouthCoast Research Center
Miami, Florida, 33136, United States
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144, United States
Florida Craniofacial Institute
Tampa, Florida, 33607, United States
Forcare Clinical Research
Tampa, Florida, 33613, United States
Campus Health, Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, 46202, United States
IDS-IU Simon Cancer Center (IUSCC)
Indianapolis, Indiana, 46202, United States
Indiana University School of Dentistry
Indianapolis, Indiana, 46202, United States
University of Kentucky, College of Dentistry
Lexington, Kentucky, 40536, United States
TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Clinvest Research, LLC
Springfield, Missouri, 65807, United States
Clinvest Research
Springfield, Missouri, 65810, United States
North Suffolk Neurology
Commack, New York, 11725, United States
University of Rochester
Rochester, New York, 14618, United States
Duke University
Raleigh, North Carolina, 27617, United States
META Medical Research Institute,LLC.
Dayton, Ohio, 45432, United States
Meta Medical Research
Dayton, Ohio, 45432, United States
Kulkarni Orthodonties
Springboro, Ohio, 45066, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15201, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
Red Star Research
Lake Jackson, Texas, 77566, United States
FMC Science
Lampasas, Texas, 76550, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
JBR
Salt Lake City, Utah, 84107, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian)
Seattle, Washington, 98121, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2022
First Posted
March 2, 2022
Study Start
May 5, 2022
Primary Completion
May 18, 2023
Study Completion
May 18, 2023
Last Updated
May 16, 2024
Results First Posted
May 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.