Clinical trial NCT05262517: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Temporomandibular Disorders (TMD)
Keywords: Temporomandibular Disorders
TMD
Temporomandibular Joint
TMJ
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2)
timeFrame: Baseline (0 hours) to 2-hours post-dose
measure: SPID From Baseline to 24-Hours Post-dose (SPID-24)
timeFrame: Baseline (0 hours) to 24-hours post-dose
Secondary outcomes:
measure: Change From Baseline in NRS Score at 2-Hours Post-Dose
timeFrame: Baseline (0 hours), 2-hours post-dose
measure: Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose
timeFrame: Baseline (0 hour) to 2-hours post-dose
measure: Time to Onset of Meaningful Pain Relief
timeFrame: Baseline (0 hours) up to 24 hours post-dose
measure: Time to Onset of Initial Pain Relief
timeFrame: Baseline (0 hour) to 24 hours post-dose
measure: Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose
timeFrame: Through 24 hours post-dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Bruce Nelson, DDS
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Hollywood
country: United States
facility: The Medici Medical Research, LLC
state: Florida
city: Hollywood
country: United States
facility: The Medici Medical Research
state: Florida
city: Miami
country: United States
facility: SouthCoast Research Center, Inc
state: Florida
city: Miami
country: United States
facility: SouthCoast Research Center
state: Florida
city: Miami
country: United States
facility: Oceane7 Medical & Research Center, Inc.
state: Florida
city: Tampa
country: United States
facility: Florida Craniofacial Institute
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Campus Health, Indiana University-Purdue University Indianapolis
state: Indiana
city: Indianapolis
country: United States
facility: IDS-IU Simon Cancer Center (IUSCC)
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky, College of Dentistry
state: Kentucky
city: Minneapolis
country: United States
facility: TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Commack
country: United States
facility: North Suffolk Neurology
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Raleigh
country: United States
facility: Duke University
state: North Carolina
city: Dayton
country: United States
facility: META Medical Research Institute,LLC.
state: Ohio
city: Dayton
country: United States
facility: Meta Medical Research
state: Ohio
city: Springboro
country: United States
facility: Kulkarni Orthodonties
state: Ohio
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: JBR
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian)
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: