Temporomandibular Disorders (TMD)Phase 3NCT05262517
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders
A Phase 3 study testing Rimegepant in people with Temporomandibular Disorders (TMD), run by Pfizer at 32 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Rimegepant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 32 sitesUnited States
- Study dates
- 5 May 2022to 18 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Northwest Clinical Research Center
Bellevue, Washington, 98007
North Suffolk Neurology
Commack, New York, 11725
META Medical Research Institute,LLC.
Dayton, Ohio, 45432
Meta Medical Research
Dayton, Ohio, 45432
The Medici Medical Research, LLC
Hollywood, Florida, 33021
The Medici Medical Research
Hollywood, Florida, 33021
Campus Health, Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, 46202
IDS-IU Simon Cancer Center (IUSCC)
Indianapolis, Indiana, 46202
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
Red Star Research, LLC
Lake Jackson, Texas, 77566
Red Star Research
Lake Jackson, Texas, 77566
FMC Science
Lampasas, Texas, 76550
University of Kentucky, College of Dentistry
Lexington, Kentucky, 40536
SouthCoast Research Center, Inc
Miami, Florida, 33136
SouthCoast Research Center
Miami, Florida, 33136
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144
TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota
Minneapolis, Minnesota, 55455
University of Minnesota
Minneapolis, Minnesota, 55455
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Bruce Nelson, DDS
Phoenix, Arizona, 85020
Arizona Research Center
Phoenix, Arizona, 85053
University of Pittsburgh
Pittsburgh, Pennsylvania, 15201
Duke University
Raleigh, North Carolina, 27617
University of Rochester
Rochester, New York, 14618
JBR Clinical Research
Salt Lake City, Utah, 84107
JBR
Salt Lake City, Utah, 84107
Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian)
Seattle, Washington, 98121
Kulkarni Orthodonties
Springboro, Ohio, 45066
Clinvest Research, LLC
Springfield, Missouri, 65807
Clinvest Research
Springfield, Missouri, 65810
Florida Craniofacial Institute
Tampa, Florida, 33607
Forcare Clinical Research
Tampa, Florida, 33613
About this study
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)
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.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Rimegepant, Placebo
- Keywords
- Temporomandibular Disorders, TMD, Temporomandibular Joint, TMJ
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Also called BHV3000
75 mg ODT
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| BHV3000 (rimegepant) | Experimental | One dose of rimegepant 75 mg ODT Receives: Drug: Rimegepant |
| Matching Placebo | Placebo comparator | One dose of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline (0 hours) to 24-hours post-dose
Secondary outcomes (5)
Change From Baseline in NRS Score at 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."
Measured: Baseline (0 hours), 2-hours post-dose
Percentage of Participants Who Experienced Pain Freedom at 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."
Measured: Baseline (0 hour) to 2-hours post-dose
Time to Onset of Meaningful Pain Relief
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.
Measured: Baseline (0 hours) up to 24 hours post-dose
Time to Onset of Initial Pain Relief
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.
Measured: Baseline (0 hour) to 24 hours post-dose
Percentage of Participants Using Rescue Medication Within 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.
Measured: Through 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 May 2022
- Primary completion18 May 2023
- Study completion18 May 2023
Why it stopped: Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262517
- Sponsor's protocol ID
- BHV3000-317
- Other IDs
- C4951016
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2022
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05262517
- Acronym / sponsor ID
- BHV3000-317
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Temporomandibular Disorders, TMD, Temporomandibular Joint, TMJ
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV3000 (rimegepant) | Experimental | Drug: RimegepantOne dose of rimegepant 75 mg ODT |
| Matching Placebo | Placebo comparator | Drug: PlaceboOne dose of matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantAlso: BHV300075 mg ODT | Drug | BHV3000 (rimegepant) |
| Placebomatching placebo | Drug | Matching Placebo |
Primary outcome
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).
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).
5 secondary outcomes
Change From Baseline in NRS Score at 2-Hours Post-Dose
Time frame: 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
Time to Onset of Meaningful Pain Relief
Time frame: 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
Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose
Time frame: Through 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Temporomandibular Disorders (TMD)
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimegepant in people with Temporomandibular Disorders (TMD), run by Pfizer at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.