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

May 7, 2024 updated by: Pfizer

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85020
        • Bruce Nelson, DDS
    • Florida
      • Hollywood, Florida, United States, 33021
        • The Medici Medical Research, LLC
      • Hollywood, Florida, United States, 33021
        • The Medici Medical Research
      • Miami, Florida, United States, 33136
        • SouthCoast Research Center
      • Miami, Florida, United States, 33144
        • Oceane7 Medical & Research Center, Inc.
      • Miami, Florida, United States, 33136
        • SouthCoast Research Center, Inc
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
      • Tampa, Florida, United States, 33607
        • Florida Craniofacial Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Dentistry
      • Indianapolis, Indiana, United States, 46202
        • Campus Health, Indiana University-Purdue University Indianapolis
      • Indianapolis, Indiana, United States, 46202
        • IDS-IU Simon Cancer Center (IUSCC)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, College of Dentistry
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota
    • Missouri
      • Springfield, Missouri, United States, 65810
        • Clinvest Research
      • Springfield, Missouri, United States, 65807
        • Clinvest Research, LLC
    • New York
      • Commack, New York, United States, 11725
        • North Suffolk Neurology
      • Rochester, New York, United States, 14618
        • University of Rochester
    • North Carolina
      • Raleigh, North Carolina, United States, 27617
        • Duke University
    • Ohio
      • Dayton, Ohio, United States, 45432
        • META Medical Research Institute,LLC.
      • Dayton, Ohio, United States, 45432
        • Meta Medical Research
      • Springboro, Ohio, United States, 45066
        • Kulkarni Orthodonties
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, United States, 15201
        • University of Pittsburgh
    • Texas
      • Lake Jackson, Texas, United States, 77566
        • Red Star Research, LLC
      • Lake Jackson, Texas, United States, 77566
        • Red Star Research
      • Lampasas, Texas, United States, 76550
        • FMC Science
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
      • Salt Lake City, Utah, United States, 84107
        • JBR
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98121
        • Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BHV3000 (rimegepant)
One dose of rimegepant 75 mg ODT
Drug: Rimegepant
75 mg ODT
Other Names:
  • BHV3000
Placebo Comparator: Matching Placebo
One dose of matching placebo
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2)
Time Frame: 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).
Baseline (0 hours) to 2-hours post-dose
SPID From Baseline to 24-Hours Post-dose (SPID-24)
Time Frame: 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).
Baseline (0 hours) to 24-hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in NRS Score at 2-Hours Post-Dose
Time Frame: 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."
Baseline (0 hours), 2-hours post-dose
Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose
Time Frame: 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."
Baseline (0 hour) to 2-hours post-dose
Time to Onset of Meaningful Pain Relief
Time Frame: 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.
Baseline (0 hours) up to 24 hours post-dose
Time to Onset of Initial Pain Relief
Time Frame: 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.
Baseline (0 hour) to 24 hours post-dose
Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose
Time Frame: 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.
Through 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biohaven Pharmaceutical Holding Company Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHV3000-317
  • C4951016 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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