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

Sponsor

Biohaven Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05262517

Collaborator

Biohaven Pharmaceutical Holding Company Ltd. (Industry)

200

Enrollment

Locations

Arms

9.9

Anticipated Duration (Months)

11.1

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorders (TMD)	Drug: Rimegepant Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

May 5, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of Temporomandibular Disorders [First 2 hours post-dose]
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) [First 24 hours post-dose]
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 [2 hours post-dose]
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 [2 hours post-dose]
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 [Number of minutes post dose in which pain decreases by 30%]
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 [Number of minutes post dose in which pain decreased by 1 point]
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 [Within 24 hours of initial treatment]
Assessed using the number of subjects that take rescue medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Research Center	Phoenix	Arizona	United States	85053
2	The Medici Medical Research	Hollywood	Florida	United States	33021
3	SouthCoast Research Center	Miami	Florida	United States	33136
4	Oceane7 Medical & Research Center, Inc.	Miami	Florida	United States	33144
5	ForCare Clinical Research	Tampa	Florida	United States	33613
6	Indiana University School of Dentistry	Indianapolis	Indiana	United States	46202
7	University of Minnesota	Minneapolis	Minnesota	United States	55455
8	Clinvest Research	Springfield	Missouri	United States	65810
9	North Suffolk Neurology	Commack	New York	United States	11725
10	University of Rochester	Rochester	New York	United States	14618
11	EIOH, University of Rochester	Rochester	New York	United States	14620
12	Duke University	Raleigh	North Carolina	United States	27617
13	Meta Medical Research	Dayton	Ohio	United States	45432
14	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania	United States	19104
15	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15201
16	Red Star Research	Lake Jackson	Texas	United States	77566
17	JBR	Salt Lake City	Utah	United States	84107
18	Northwest Clinical Research Center	Bellevue	Washington	United States	98007