search
Back to results

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

Primary Purpose

Temporomandibular Disorders (TMD)

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rimegepant
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders (TMD) focused on measuring Temporomandibular Disorders, TMD, Temporomandibular Joint, TMJ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bruce Nelson, DDS
  • Arizona Research Center
  • The Medici Medical Research, LLC
  • The Medici Medical Research
  • SouthCoast Research Center, Inc
  • SouthCoast Research Center
  • Oceane7 Medical & Research Center, Inc.
  • Florida Craniofacial Institute
  • Forcare Clinical Research
  • Campus Health, Indiana University-Purdue University Indianapolis
  • IDS-IU Simon Cancer Center (IUSCC)
  • Indiana University School of Dentistry
  • University of Kentucky, College of Dentistry
  • TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota
  • University of Minnesota
  • Clinvest Research, LLC
  • Clinvest Research
  • North Suffolk Neurology
  • University of Rochester
  • Duke University
  • META Medical Research Institute,LLC.
  • Meta Medical Research
  • Kulkarni Orthodonties
  • Perelman Center for Advanced Medicine
  • University of Pittsburgh
  • Red Star Research, LLC
  • Red Star Research
  • FMC Science
  • JBR Clinical Research
  • JBR
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BHV3000 (rimegepant)

Matching Placebo

Arm Description

One dose of rimegepant 75 mg ODT

One dose of matching placebo

Outcomes

Primary Outcome Measures

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of Temporomandibular Disorders
Assessed by calculating the Sum of Pain Intensity Difference (SPID-2) derived by using the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)

Secondary Outcome Measures

To evaluate rimegepant compared to placebo on the weighted Sum of Pain Intensity Difference (SPID-24)
Assessed by calculating the Sum of Pain Intensity Difference (SPID-24) derived by using the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
To evaluate rimegepant compared to placebo on change from baseline of pain
Assessed on the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
To evaluate rimegepant compared to placebo on the proportion of subjects that are pain free
Assessed using the number of evaluable subjects that report no pain measured on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
To evaluate rimegepant compared to placebo on time to onset of meaningful pain relief
Assessed by the first nominal timepoint at which the pain on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) decreases by 30%
To evaluate rimegepant compared to placebo on time to onset of initial pain relief
Assessed by the first nominal timepoint at which the pain on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) decreases by 1 point
To evaluate rimegepant compared to placebo on the probability of requiring rescue medication
Assessed using the number of subjects that take rescue medication

Full Information

First Posted
February 21, 2022
Last Updated
July 31, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05262517
Brief Title
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders (TMD)
Keywords
Temporomandibular Disorders, TMD, Temporomandibular Joint, TMJ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BHV3000 (rimegepant)
Arm Type
Experimental
Arm Description
One dose of rimegepant 75 mg ODT
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
One dose of matching placebo
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Other Intervention Name(s)
BHV3000
Intervention Description
75 mg ODT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of Temporomandibular Disorders
Description
Assessed by calculating the Sum of Pain Intensity Difference (SPID-2) derived by using the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
Time Frame
First 2 hours post-dose
Secondary Outcome Measure Information:
Title
To evaluate rimegepant compared to placebo on the weighted Sum of Pain Intensity Difference (SPID-24)
Description
Assessed by calculating the Sum of Pain Intensity Difference (SPID-24) derived by using the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
Time Frame
First 24 hours post-dose
Title
To evaluate rimegepant compared to placebo on change from baseline of pain
Description
Assessed on the Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
Time Frame
2 hours post-dose
Title
To evaluate rimegepant compared to placebo on the proportion of subjects that are pain free
Description
Assessed using the number of evaluable subjects that report no pain measured on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable)
Time Frame
2 hours post-dose
Title
To evaluate rimegepant compared to placebo on time to onset of meaningful pain relief
Description
Assessed by the first nominal timepoint at which the pain on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) decreases by 30%
Time Frame
Number of minutes post dose in which pain decreases by 30%
Title
To evaluate rimegepant compared to placebo on time to onset of initial pain relief
Description
Assessed by the first nominal timepoint at which the pain on Numerical Rating Scale (NRS) 0-10 score (0 = No Pain, 10 = worst pain imaginable) decreases by 1 point
Time Frame
Number of minutes post dose in which pain decreased by 1 point
Title
To evaluate rimegepant compared to placebo on the probability of requiring rescue medication
Description
Assessed using the number of subjects that take rescue medication
Time Frame
Within 24 hours of initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Bruce Nelson, DDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
The Medici Medical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
The Medici Medical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
SouthCoast Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
SouthCoast Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Oceane7 Medical & Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Florida Craniofacial Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Forcare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Campus Health, Indiana University-Purdue University Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IDS-IU Simon Cancer Center (IUSCC)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University School of Dentistry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky, College of Dentistry
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Clinvest Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
North Suffolk Neurology
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke University
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
META Medical Research Institute,LLC.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Meta Medical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Kulkarni Orthodonties
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15201
Country
United States
Facility Name
Red Star Research, LLC
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Red Star Research
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
JBR
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-317
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs