Trial · NCT03941834
Trial for Treatment Refractory Trigeminal Neuralgia
NCT03941834, Phase 2, Terminated, Pfizer; results first posted 2024-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial for Treatment Refractory Trigeminal Neuralgia. Trials, record NCT03941834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03941834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial for Treatment Refractory Trigeminal Neuralgia
- NCT number
- NCT03941834
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Trigeminal Neuralgia
- Interventions
- Rimegepant, Placebo
- First posted
- 2019-05-08
- Last updated
- 2024-06-10
- Results first posted
- 2024-06-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment | 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. |
| 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 | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) | 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. |
| Secondary | Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. |
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) | 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. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) | 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. |
| Secondary | Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. |
| Secondary | Change From Baseline in Pain Disability Index Total Score at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. |
| Secondary | Patient Global Impression of Change Scale (PGI-C) Score at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. |
| Secondary | Change From Baseline in Average Worst Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. |
| Secondary | Percentage of Participants With >= 2 Point Reduction From Baseline in Average Daily Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| 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 | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase | DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain Disability Index Total Score at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Change Scale (PGI-C) Score at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Worst Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With >= 2 Point Reduction From Baseline in Average Daily Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase | DBT Phase: Baseline, 2 Weeks Treatment | 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. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase | DBT Phase: Pooled Rimegepant | -.5 | 95% Confidence Interval -1.1 to -.1 | Units on a scale | |
| Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase | DBT Phase: Pooled Placebo | -1.2 | 95% Confidence Interval -1.8 to -0.6 | Units on a scale | |
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | DBT Phase: Pooled Rimegepant | SAEs | 0 | Participants | |
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | DBT Phase: Pooled Placebo | SAEs | 0 | Participants | |
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | DBT Phase: Pooled Rimegepant | AEs Leading to Study Drug Discontinuation | 0 | Participants | |
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | DBT Phase: Pooled Placebo | AEs Leading to Study Drug Discontinuation | 0 | Participants | |
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | DBT Phase: Pooled Rimegepant | Treatment Related AEs | 4 | Participants | |
| Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase | DBT Phase: Pooled Placebo | Treatment Related AEs | 0 | Participants | |
| Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | DBT Phase: Pooled Rimegepant | 0 | Participants | ||
| Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | DBT Phase: Pooled Placebo | 0 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DBT Phase: 1st Treatment Period (2Weeks) | STARTED | DBT Phase: Placebo Then Rimegepant (BHV-3000) | 15 | |
| DBT Phase: 1st Treatment Period (2Weeks) | STARTED | DBT Phase: Rimegepant Then Placebo | 15 | |
| DBT Phase: 1st Treatment Period (2Weeks) | STARTED | OLE Phase: Rimegepant | 0 | |
| DBT Phase: 1st Treatment Period (2Weeks) | Treated | DBT Phase: Placebo Then Rimegepant (BHV-3000) | 15 | |
| DBT Phase: 1st Treatment Period (2Weeks) | Treated | DBT Phase: Rimegepant Then Placebo | 14 | |
| DBT Phase: 1st Treatment Period (2Weeks) | Treated | OLE Phase: Rimegepant | 0 | |
| DBT Phase: 1st Treatment Period (2Weeks) | COMPLETED | DBT Phase: Placebo Then Rimegepant (BHV-3000) | 14 | |
| DBT Phase: 1st Treatment Period (2Weeks) | COMPLETED | DBT Phase: Rimegepant Then Placebo | 14 | |
| DBT Phase: 1st Treatment Period (2Weeks) | COMPLETED | OLE Phase: Rimegepant | 0 | |
| DBT Phase: 1st Treatment Period (2Weeks) | NOT COMPLETED | DBT Phase: Placebo Then Rimegepant (BHV-3000) | 1 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events77
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 1/ Period 1: Placebo | 0 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 1/ Period 2: Rimegepant | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 2/ Period 1: Rimegepant | 0 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 2/ Period 2: Placebo | 0 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | DBT Phase: Pooled Rimegepant | 1 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | DBT Phase: Pooled Placebo | 0 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | OLE Phase: Rimegepant | 0 | 13 | |
| other | Abdominal tenderness | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 1/ Period 1: Placebo | 0 | 15 | |
| other | Abdominal tenderness | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 1/ Period 2: Rimegepant | 1 | 14 | |
| other | Abdominal tenderness | Gastrointestinal disorders | DBT Phase/ Treatment Sequence 2/ Period 1: Rimegepant | 0 | 14 |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DBT Phase/ Treatment Sequence 1/ Period 1: Placebo | 0 | 15 |
| Total, all-cause mortality | DBT Phase/ Treatment Sequence 1/ Period 2: Rimegepant | 0 | 14 |
| Total, all-cause mortality | DBT Phase/ Treatment Sequence 2/ Period 1: Rimegepant | 0 | 14 |
| Total, all-cause mortality | DBT Phase/ Treatment Sequence 2/ Period 2: Placebo | 0 | 14 |
| Total, all-cause mortality | DBT Phase: Pooled Rimegepant | 0 | 28 |
| Total, all-cause mortality | DBT Phase: Pooled Placebo | 0 | 29 |
| Total, all-cause mortality | OLE Phase: Rimegepant | 0 | 13 |
| Total, other adverse events | DBT Phase/ Treatment Sequence 1/ Period 1: Placebo | 1 | 15 |
| Total, other adverse events | DBT Phase/ Treatment Sequence 1/ Period 2: Rimegepant | 3 | 14 |
| Total, other adverse events | DBT Phase/ Treatment Sequence 2/ Period 1: Rimegepant | 3 | 14 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DBT Phase: Pooled Rimegepant vs DBT Phase: Pooled Placebo: Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase | Trial comparisons |
| DBT Phase: Pooled Rimegepant vs DBT Phase: Pooled Placebo: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase | Trial comparisons |
| DBT Phase: Pooled Rimegepant vs DBT Phase: Pooled Placebo: Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03941834
GET https://conductscience.org/api/trials/v1/NCT03941834/results?page=2