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| ID | Type | Description | Link |
|---|---|---|---|
| C4951016 | Other Identifier | Alias Study Number |
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Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV3000 (rimegepant) | Experimental | One dose of rimegepant 75 mg ODT |
|
| Matching Placebo | Placebo Comparator | One dose of matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | 75 mg ODT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Baseline (0 hours) to 24-hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline (0 hours), 2-hours post-dose |
| Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose |
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Inclusion Criteria:
* Subject has a minimum 3-month to a maximum 5-year history of temporomandibular disorder diagnosed by a healthcare provider.
Exclusion Criteria:
* Subject has an exclusionary headache, joint, pain, connective tissue, or developmental disorder.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruce Nelson, DDS | Phoenix | Arizona | 85020 | United States | ||
| Arizona Research Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Participants were to administer one dose of study medication only when temporomandibular disorders (TMD)-associated pain in the jaw and/or temple area on either side reached pain intensity of greater than or equal to (>=) 6 on the numeric rating scale (NRS) in the electronic (e)-diary within 45 days of randomization.
A total of 126 participants were enrolled in the study. Only 87 participants were randomized to treatment and only 71 participants were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimegepant (BHV3000) | Participants were randomized for administration of rimegepant 75 milligram (mg) single dose as orally disintegrated tablet (ODT) sublingually. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2022 | Apr 12, 2024 |
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| Placebo | Drug | matching placebo |
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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 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 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 | 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 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| The Medici Medical Research, LLC | Hollywood | Florida | 33021 | United States |
| The Medici Medical Research | Hollywood | Florida | 33021 | United States |
| SouthCoast Research Center, Inc | Miami | Florida | 33136 | United States |
| SouthCoast Research Center | Miami | Florida | 33136 | United States |
| Oceane7 Medical & Research Center, Inc. | Miami | Florida | 33144 | United States |
| Florida Craniofacial Institute | Tampa | Florida | 33607 | United States |
| Forcare Clinical Research | Tampa | Florida | 33613 | United States |
| Campus Health, Indiana University-Purdue University Indianapolis | Indianapolis | Indiana | 46202 | United States |
| IDS-IU Simon Cancer Center (IUSCC) | Indianapolis | Indiana | 46202 | United States |
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky, College of Dentistry | Lexington | Kentucky | 40536 | United States |
| TMD, Orofacial Pain and Dental Sleep Medicine Clinic, School of Dentistry, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Clinvest Research, LLC | Springfield | Missouri | 65807 | United States |
| Clinvest Research | Springfield | Missouri | 65810 | United States |
| North Suffolk Neurology | Commack | New York | 11725 | United States |
| University of Rochester | Rochester | New York | 14618 | United States |
| Duke University | Raleigh | North Carolina | 27617 | United States |
| META Medical Research Institute,LLC. | Dayton | Ohio | 45432 | United States |
| Meta Medical Research | Dayton | Ohio | 45432 | United States |
| Kulkarni Orthodonties | Springboro | Ohio | 45066 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15201 | United States |
| Red Star Research, LLC | Lake Jackson | Texas | 77566 | United States |
| Red Star Research | Lake Jackson | Texas | 77566 | United States |
| FMC Science | Lampasas | Texas | 76550 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| JBR | Salt Lake City | Utah | 84107 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Snoring and Sleep Apnea Center (DC/TMD Exam - Dr. Christian) | Seattle | Washington | 98121 | United States |
Participants were randomized for administration of single dose of placebo matching to rimegepant.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis population included participants who were enrolled and received at least 1 dose of study medication. Baseline characteristics tabulated by the treated analysis set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant (BHV3000) | Participants were randomized for administration of rimegepant 75 mg single dose as ODT sublingually. |
| BG001 | Placebo | Participants were randomized for administration of single dose of placebo matching to rimegepant. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. Missing postbaseline NRS assessments were imputed as the last non-missing observation prior to the missing assessment. Missing baseline assessments were imputed as the mean of the non-missing baseline assessments across participants. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (0 hours) to 2-hours post-dose |
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| Primary | 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). | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. Missing postbaseline NRS assessments were imputed as the last non-missing observation prior to the missing assessment. Missing baseline assessments were imputed as the mean of the non-missing baseline assessments across participants. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on a scale | Baseline (0 hours) to 24-hours post-dose |
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| Secondary | 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." | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (0 hours), 2-hours post-dose |
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| Secondary | 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." | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. Participants who (1) had missing data at 2-hours post-dose or (2) took rescue medication at or before 2-hours post-dose were imputed as failures. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (0 hour) to 2-hours post-dose |
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| Secondary | 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. | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. | Posted | Median | 95% Confidence Interval | Minutes | Baseline (0 hours) up to 24 hours post-dose |
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| Secondary | 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. | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. | Posted | Median | 95% Confidence Interval | Minutes | Baseline (0 hour) to 24 hours post-dose |
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| Secondary | 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. | Treated analysis population included enrolled participants who took study therapy (rimegepant or placebo); i.e., non-missing study drug start date. | Posted | Number | 95% Confidence Interval | Percentage of participants | Through 24 hours post-dose |
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Randomization up to 7 days after study medication administration (maximum up to 52 days, if study medication took on 45th day post randomization, single dose was to be administered on any day from randomization to 45 days post randomization, only when NRS>=6)
Treated analysis set evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimegepant (BHV3000) | Participants were randomized for administration of rimegepant 75 mg single dose as ODT sublingually. | 0 | 39 | 0 | 39 | 1 | 39 |
| EG001 | Placebo | Participants were randomized for administration of single dose of placebo matching to rimegepant. | 0 | 32 | 0 | 32 | 3 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block right | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2023 | Apr 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 |
| Placebo |
Participants were randomized for administration of single dose of placebo matching to rimegepant. |
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