Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C4951014 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of BHV3000 compared to placebo for subjects with treatment refractory Trigeminal Neuralgia as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale between the two-week treatment phases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV3000 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | BHV3000 (rimegepant) 75mg tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase | NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period on NPRS. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure. | DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect other important medical events. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to drug was assessed by investigator. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilbert Neurology Partners, PLLC/CCT Research | Gilbert | Arizona | 85297 | United States | ||
| Center for Neurohealth DBA Kaizen Brain Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Out of 65 participants, only 30 were randomized in DBT phase, and 35 participants were not randomized (screen failure [28], sponsor decision [1], medical monitor decision [1], physician decision [1], withdrawal of consent [4]).
There were 2 phases in the study: double blind treatment (DBT) phase followed by open label extension (OLE) phase. Participants after completing DBT phase could enter OLE phase if the Principal Investigator (PI) believed open-label treatment offered an acceptable risk-benefit profile. A total of 65 participants with refractory trigeminal neuralgia (TN) were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DBT Phase: Placebo Then Rimegepant (BHV-3000) | Participants included in this arm were randomized to first sequence. Participants in first treatment period received placebo (matched to rimegepant) orally once daily (QD) for 2 weeks and in second treatment period received rimegepant 75 milligram (mg) immediate release (IR) tablet orally QD for 2 weeks. Treatment periods were separated by a washout period of 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DBT Phase: 1st Treatment Period (2Weeks) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2022 | May 7, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) |
| Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | S-STS is a scale that assesses the seriousness of suicidality phenomena on a 5-point Likert-type scale (0 to 4) ranging from "not at all" (0) to "extremely" (4), where higher scores signify suicidal tendency. In this outcome measure, number of participants who had any change in S-STS score from baseline to end of treatment are reported according to the treatment received in first or second treatment period of DBT phase. | DBT Phase: Baseline, 2 Weeks Treatment |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase | ECG abnormalities included were a Corrected QT interval exceeding 470 milliseconds (QTc calculated using the Frederica method), left bundle branch block, right bundle branch block with a QRS duration of 150 milliseconds or more, and intraventricular conduction defect with a QRS duration equal to or greater than 150 milliseconds. Clinical significance in ECG abnormalities was judged by investigator. | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) |
| Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase | Laboratory abnormalities included 1)Hematology: hemoglobin, hematocrit, platelets, complete blood count with differential and absolute neutrophil count; 2)Serum chemistry: sodium, potassium, chloride, calcium, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, gamma-glutamyl transferase, phosphorus, bicarbonate, creatine phosphokinase, total protein, albumin, total bilirubin, glucose, creatinine, blood urea nitrogen, uric acid, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, folate, hemoglobin A1C, pancreatic amylase or lipase, thyroid-stimulating Hormone, thyroxine; 3)Urinalysis: macroscopic examination, pH, specific gravity, ketones, nitrites, urobilinogen, leukocyte esterase, protein, glucose, occult blood; 4)Liver function tests: alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase. Clinical significance in laboratory abnormalities was judged by investigator. | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) |
| Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase | Penn-FPS-R: a 12-item scale, utilized to evaluate the impact of TN pain on health-related quality of life and daily activities. Each 12 items ranged from 0 (does not interfere) to 10 (completely interferes). Penn-FPS-R total score was calculated by adding scores of all items and had a score range of (does not interfere) 0 to 120 (completely interferes).Higher Penn-FPS-R total scores signifies worse condition. Participants were asked to complete the Penn-FPS-R at the beginning and end of each treatment period. Average of total Penn-FPS-score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure. | DBT Phase: Baseline, 2 Weeks Treatment |
| Change From Baseline in Pain Disability Index Total Score at 2 Week Treatment Phase: DBT Phase | Pain disability index measures the extent of disruption in a participant's daily life caused by pain, utilizing a 7-item scale scored on an 11-point Likert Scale, where "0" denotes "no disability," and "10" indicates "worst disability". Higher scores signify worse outcome. Pain disability index total score was calculated by adding scores of all the 7 items and had a score range of 0 to 70. Higher pain disability index total scores signifies worse condition. Participants were instructed to complete the pain disability index at the beginning and end of each treatment period. Average of pain disability index total scores according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure. | DBT Phase: Baseline, 2 Weeks Treatment |
| Patient Global Impression of Change Scale (PGI-C) Score at 2 Week Treatment Phase: DBT Phase | PGI-C is a participant-reported scale utilized to evaluate the improvement or deterioration of the participant's current illness status compared to the baseline visit. Participants were asked to rate a change in their overall disease condition on a 7-point scale, ranging from 1 (no change) to 7 (a great deal better). Higher PGI-C scores signify better outcome. PGI-C assessments were conducted at the beginning and end of each treatment phase. Average of PGI-C score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure. | DBT Phase: Baseline, 2 Weeks Treatment |
| Change From Baseline in Average Worst Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their worst pain rating over a 24-hour period on NPRS. Average of worst pain NPRS score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure. | DBT Phase: Baseline, 2 Weeks Treatment |
| Percentage of Participants With >= 2 Point Reduction From Baseline in Average Daily Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT Phase are used in evaluation of the outcome measure. | DBT Phase: Baseline, 2 Weeks Treatment |
| La Jolla |
| California |
| 92037 |
| United States |
| Imaging Clinic at Stanford Neuroscience Health Center | Palo Alto | California | 94304 | United States |
| Stanford Hoover Pavilion | Palo Alto | California | 94304 | United States |
| Stanford Neuroscience Health Center- SNHC Pharmacy | Palo Alto | California | 94304 | United States |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | United States |
| Stanford University- CAM Building | Stanford | California | 94305 | United States |
| SouthCoast Research Center | Miami | Florida | 33136 | United States |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | United States |
| Johns Hopkins Clinical Outpatient Center | Baltimore | Maryland | 21287 | United States |
| Johns Hopkins ICTR Clinical Research Unit (CRU) | Baltimore | Maryland | 21287 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| Neurological Surgery Practice of Long Island PLCC | Lake Success | New York | 11042 | United States |
| Neurological Surgery | Lake Success | New York | 11042 | United States |
| Premier Cardiolog Consultants | Lake Success | New York | 11042 | United States |
| Premier Cardiolog Consultants | New Hyde Park | New York | 11042 | United States |
| Premier Cardiology Consultants | New Hyde Park | New York | 11042 | United States |
| North Suffolk Neurology, PC | Port Jefferson Station | New York | 11776 | United States |
| Neurology Diagnostics Inc. | Dayton | Ohio | 45459 | United States |
| FG001 | DBT Phase: Rimegepant Then Placebo | Participants in first treatment period received rimegepant 75 mg IR tablet orally QD for 2 weeks and in second period received placebo (matched to rimegepant) QD for 2 weeks. Treatment periods were separated by a washout period of 7 days. |
| FG002 | OLE Phase: Rimegepant | Participants who completed DBT phase, were eligible per PI judgment and agreed to enter OLE phase, received rimegepant 75 mg Orally disintegrating tablet (ODT) QD for 12 weeks in OLE phase. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| DBT Phase: Washout Period (7 Days) |
|
| 2nd Treatment Period (2Weeks) |
|
| OLE Phase (12 Weeks) |
|
|
Participants who received at least 1 dose of double-blind study drug in DBT phase and OLE phase. Participants in DBT and OLE phases are not exclusive. Eligible participants from DBT phase entered OLE phase after completing treatment in DBT phase.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DBT: Placebo Then Rimegepant | Participants in first treatment period received placebo (matched to rimegepant) QD for 2 weeks and in second treatment period received rimegepant 75 mg IR tablet orally QD for 2 weeks. |
| BG001 | DBT Phase: Rimegepant Then Placebo | Participants in first treatment period received rimegepant 75 mg IR tablet orally QD for 2 weeks and in second treatment period received placebo (matched to rimegepant) QD for 2 weeks. |
| BG002 | OLE Phase: Rimegepant | Participants received rimegepant 75 mg ODT QD for 12 weeks in OLE phase. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number Analyzed for DBT Phase and OLE Phase = number of participants analyzed for reporting arms for respective phases. Participants in DBT and OLE phases are not exclusive. | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | Number Analyzed for DBT Phase and OLE Phase = number of participants analyzed for reporting arms for respective phases. Participants in DBT and OLE phases are not exclusive. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Number Analyzed for DBT Phase and OLE Phase= number of participants analyzed for reporting arms for respective phases. Participants in DBT and OLE phases are not exclusive. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Number Analyzed for DBT Phase and OLE Phase = number of participants analyzed for reporting arms for respective phases. Participants in DBT and OLE phases are not exclusive. | Count of Participants | Participants |
|
| 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 | Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase | NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period on NPRS. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure. | Modified intent-to-treat (mITT) analysis set included randomized participants who received at least 1 dose of study therapy and provided a baseline and at least one post-baseline efficacy assessment in each sequence. Here, "Number of Participants Analyzed" signifies number of participants in mITT set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect other important medical events. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to drug was assessed by investigator. | DBT treated set consisted of participants in the treated analysis set who took >= 1 dose of DB study drug (rimegepant or placebo), i.e., non-missing study drug start date. Here, "Number of Participants Analyzed" signifies number of participants in DBT treated set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Count of Participants | Participants | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | S-STS is a scale that assesses the seriousness of suicidality phenomena on a 5-point Likert-type scale (0 to 4) ranging from "not at all" (0) to "extremely" (4), where higher scores signify suicidal tendency. In this outcome measure, number of participants who had any change in S-STS score from baseline to end of treatment are reported according to the treatment received in first or second treatment period of DBT phase. | DBT treated set consisted of participants in the treated analysis set who took >= 1 dose of DB study drug (rimegepant or placebo), i.e., non-missing study drug start date. Here, "Number of Participants Analyzed" signifies number of participants in DBT treated set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Count of Participants | Participants | DBT Phase: Baseline, 2 Weeks Treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase | ECG abnormalities included were a Corrected QT interval exceeding 470 milliseconds (QTc calculated using the Frederica method), left bundle branch block, right bundle branch block with a QRS duration of 150 milliseconds or more, and intraventricular conduction defect with a QRS duration equal to or greater than 150 milliseconds. Clinical significance in ECG abnormalities was judged by investigator. | DBT treated set consisted of participants in the treated analysis set who took >= 1 dose of DB study drug (rimegepant or placebo), i.e., non-missing study drug start date. Here, "Number of Participants Analyzed" signifies number of participants in DBT treated set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Count of Participants | Participants | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase | Laboratory abnormalities included 1)Hematology: hemoglobin, hematocrit, platelets, complete blood count with differential and absolute neutrophil count; 2)Serum chemistry: sodium, potassium, chloride, calcium, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, gamma-glutamyl transferase, phosphorus, bicarbonate, creatine phosphokinase, total protein, albumin, total bilirubin, glucose, creatinine, blood urea nitrogen, uric acid, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, folate, hemoglobin A1C, pancreatic amylase or lipase, thyroid-stimulating Hormone, thyroxine; 3)Urinalysis: macroscopic examination, pH, specific gravity, ketones, nitrites, urobilinogen, leukocyte esterase, protein, glucose, occult blood; 4)Liver function tests: alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase. Clinical significance in laboratory abnormalities was judged by investigator. | DBT treated set consisted of participants in the treated analysis set who took >= 1 dose of DB study drug (rimegepant or placebo), i.e., non-missing study drug start date. Here, "Number of Participants Analyzed" signifies number of participants in DBT treated set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Count of Participants | Participants | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase | Penn-FPS-R: a 12-item scale, utilized to evaluate the impact of TN pain on health-related quality of life and daily activities. Each 12 items ranged from 0 (does not interfere) to 10 (completely interferes). Penn-FPS-R total score was calculated by adding scores of all items and had a score range of (does not interfere) 0 to 120 (completely interferes).Higher Penn-FPS-R total scores signifies worse condition. Participants were asked to complete the Penn-FPS-R at the beginning and end of each treatment period. Average of total Penn-FPS-score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure. | mITT analysis set included randomized participants who received at least 1 dose of study therapy and provided a baseline and at least one post-baseline efficacy assessment in each sequence. Here, "Number of Participants Analyzed" signifies number of participants in mITT set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | DBT Phase: Baseline, 2 Weeks Treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Disability Index Total Score at 2 Week Treatment Phase: DBT Phase | Pain disability index measures the extent of disruption in a participant's daily life caused by pain, utilizing a 7-item scale scored on an 11-point Likert Scale, where "0" denotes "no disability," and "10" indicates "worst disability". Higher scores signify worse outcome. Pain disability index total score was calculated by adding scores of all the 7 items and had a score range of 0 to 70. Higher pain disability index total scores signifies worse condition. Participants were instructed to complete the pain disability index at the beginning and end of each treatment period. Average of pain disability index total scores according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure. | mITT analysis set included randomized participants who received at least 1 dose of study therapy and provided a baseline and at least one post-baseline efficacy assessment in each sequence. Here, "Number of Participants Analyzed" signifies number of participants in mITT set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | DBT Phase: Baseline, 2 Weeks Treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change Scale (PGI-C) Score at 2 Week Treatment Phase: DBT Phase | PGI-C is a participant-reported scale utilized to evaluate the improvement or deterioration of the participant's current illness status compared to the baseline visit. Participants were asked to rate a change in their overall disease condition on a 7-point scale, ranging from 1 (no change) to 7 (a great deal better). Higher PGI-C scores signify better outcome. PGI-C assessments were conducted at the beginning and end of each treatment phase. Average of PGI-C score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure. | mITT analysis set included randomized participants who received at least 1 dose of study therapy and provided a baseline and at least one post-baseline efficacy assessment in each sequence. Here, "Number of Participants Analyzed" signifies number of participants in mITT set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | DBT Phase: Baseline, 2 Weeks Treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Worst Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their worst pain rating over a 24-hour period on NPRS. Average of worst pain NPRS score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure. | mITT analysis set included randomized participants who received at least 1 dose of study therapy and provided a baseline and at least one post-baseline efficacy assessment in each sequence. Here, "Number of Participants Analyzed" signifies number of participants in mITT set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | DBT Phase: Baseline, 2 Weeks Treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 2 Point Reduction From Baseline in Average Daily Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT Phase are used in evaluation of the outcome measure. | mITT analysis set included randomized participants who received at least 1 dose of study therapy and provided a baseline and at least one post-baseline efficacy assessment in each sequence. Here, "Number of Participants Analyzed" signifies number of participants in mITT set, per treatment (pooled) received either in first or second treatment period of DBT phase. | Posted | Number | Percentage of participants | DBT Phase: Baseline, 2 Weeks Treatment |
|
Day 1 up to 2 weeks of follow up post-last dose in the study (Maximum up to 19 weeks)
Treated analysis set evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DBT Phase/ Treatment Sequence 1/ Period 1: Placebo | Participants included in this arm were randomized to first sequence to receive placebo (matched to rimegepant) orally QD for 2 weeks in Period 1. | 0 | 15 | 0 | 15 | 1 | 15 |
| EG001 | DBT Phase/ Treatment Sequence 1/ Period 2: Rimegepant | Participants included in this arm were randomized to first sequence to receive rimegepant 75 mg IR tablet orally QD for 2 weeks in Period 2. | 0 | 14 | 0 | 14 | 3 | 14 |
| EG002 | DBT Phase/ Treatment Sequence 2/ Period 1: Rimegepant | Participants included in this arm were randomized to second sequence to receive rimegepant 75 mg IR tablet orally QD for 2 weeks in Period 1. | 0 | 14 | 0 | 14 | 3 | 14 |
| EG003 | DBT Phase/ Treatment Sequence 2/ Period 2: Placebo | Participants included in this arm were randomized to second sequence to receive placebo (matched to rimegepant) orally QD for 2 weeks in Period 2. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG004 | DBT Phase: Pooled Rimegepant | Participants who received rimegepant 75 mg IR tablet in treatment period 1 or 2 of DBT phase. | 0 | 28 | 0 | 28 | 6 | 28 |
| EG005 | DBT Phase: Pooled Placebo | Participants who received placebo matched to rimegepant in treatment period 1 or 2 of DBT phase. | 0 | 29 | 0 | 29 | 1 | 29 |
| EG006 | OLE Phase: Rimegepant | Participants received rimegepant 75 mg ODT QD for 12 weeks in OLE phase. | 0 | 13 | 0 | 13 | 4 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
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 | Aug 28, 2023 | May 7, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
Not provided
Not provided
Not provided
| Sponsor decision |
|
| Withdrawal by Subject |
|
|
| OLE Phase |
|
|
|
| OLE Phase |
|
|
|
| OLE Phase |
|
|
|
| OLE Phase |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 | DBT Phase: Pooled Placebo | Participants who received placebo matched to rimegepant in treatment period 1 or 2 of DBT phase. |
|
|
Participants who received placebo matched to rimegepant in treatment period 1 or 2 of DBT phase.
|
|
|
Participants who received placebo matched to rimegepant in treatment period 1 or 2 of DBT phase. |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|