Trial · NCT04574362
Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
NCT04574362, Phase 3, Completed, Pfizer; results first posted 2023-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine. Trials, record NCT04574362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04574362
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
- NCT number
- NCT04574362
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,648 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Acute Migraine
- Interventions
- Rimegepant, Placebo
- First posted
- 2020-10-05
- Last updated
- 2023-12-14
- Results first posted
- 2023-12-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | 2 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Exact 95 percent (%) confidence interval (CI) was based on Clopper-Pearson method. |
| Primary | Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | 2 hours post-dose | MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants who reported a pain level of moderate or severe at baseline and then reported a pain level of none or mild at 2 hours post-dose, were considered to have pain relief. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | 2 hours post-dose | Participants rated the level of disability they perceived as a result of their migraine in performing normal actions using following level of severity: normal function, mild impairment, severe impairment, or required bedrest. This outcome measure was analyzed only among those participants who reported any impairment at baseline. Percentage of participants with a response of "normal function" at the 2 hours post-dose were reported in this outcome measure. |
| Secondary | Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | 24 hours post-dose | Percentage of participants who used rescue medications within 24 hours of administration of study drug were reported in this outcome measure. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose | 2 to 24 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose | 2 to 48 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 15, 30, 45, 60 and 90 minutes post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Percentage of participants who reported a pain level of moderate or severe just before taking study treatment and then reported a pain level of none at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 15, 30, 45, 60 and 90 minutes post-dose | MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants With Pain Relapse | 2 Hours to 48 Hours Post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. This outcome measure was analyzed only in those participants who were pain free at 2 hours post-dose. Percentage of participants who were pain free at 2 hours post-dose and then had a migraine of any pain severity (score 2 or 3 on the 4-point scale) within 48 hours after administration of study drug were considered to have pain relapse. Exact 95% CI was based on Clopper-Pearson method. |
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 | Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | 2 hours post-dose | Modified intent to treat (mITT) participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | 2 hours post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | 2 hours post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | 24 hours post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose | 2 to 24 hours post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose | 2 to 48 hours post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 15, 30, 45, 60 and 90 minutes post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 15, 30, 45, 60 and 90 minutes post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Relapse | 2 Hours to 48 Hours Post-dose | mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | Rimegepant 75 mg | 19.8 | 95% Confidence Interval 16.9 to 23.1 | Percentage of participants | |
| Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | Placebo | 10.7 | 95% Confidence Interval 8.5 to 13.3 | Percentage of participants | |
| Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | Rimegepant 75 mg | 50.5 | 95% Confidence Interval 46.6 to 54.3 | Percentage of participants | |
| Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | Placebo | 35.8 | 95% Confidence Interval 32.1 to 39.5 | Percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Rimegepant 75 mg | 66.5 | 95% Confidence Interval 62.8 to 70.1 | Percentage of participants | |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Placebo | 48.5 | 95% Confidence Interval 44.7 to 52.4 | Percentage of participants | |
| Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | Rimegepant 75 mg | 40.7 | 95% Confidence Interval 36.6 to 45.0 | Percentage of participants | |
| Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | Placebo | 23.8 | 95% Confidence Interval 20.3 to 27.6 | Percentage of participants | |
| Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | Rimegepant 75 mg | 8.4 | 95% Confidence Interval 6.4 to 10.8 | Percentage of participants | |
| Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | Placebo | 20.0 | 95% Confidence Interval 17.1 to 23.3 | Percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rimegepant 75 Milligram (mg) | 716 | |
| Overall Study | STARTED | Placebo | 715 | |
| Overall Study | Treated | Rimegepant 75 Milligram (mg) | 668 | |
| Overall Study | Treated | Placebo | 674 | |
| Overall Study | COMPLETED | Rimegepant 75 Milligram (mg) | 709 | |
| Overall Study | COMPLETED | Placebo | 704 | |
| Overall Study | NOT COMPLETED | Rimegepant 75 Milligram (mg) | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events194
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 | Protein urine present | Investigations | Rimegepant 75 mg | 8 | 668 | |
| other | Protein urine present | Investigations | Placebo | 7 | 674 | |
| other | Blood creatine phosphokinase increased | Investigations | Rimegepant 75 mg | 5 | 668 | |
| other | Blood creatine phosphokinase increased | Investigations | Placebo | 3 | 674 | |
| other | Blood urine present | Investigations | Rimegepant 75 mg | 3 | 668 | |
| other | Blood urine present | Investigations | Placebo | 2 | 674 | |
| other | Blood glucose increased | Investigations | Rimegepant 75 mg | 3 | 668 | |
| other | Blood glucose increased | Investigations | Placebo | 1 | 674 | |
| other | Urine leukocyte esterase positive | Investigations | Rimegepant 75 mg | 3 | 668 | |
| other | Urine leukocyte esterase positive | Investigations | Placebo | 1 | 674 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rimegepant 75 mg | 0 | 668 |
| Total, all-cause mortality | Placebo | 0 | 674 |
| Total, other adverse events | Rimegepant 75 mg | 92 | 668 |
| Total, other adverse events | Placebo | 94 | 674 |
| Total, serious adverse events | Rimegepant 75 mg | 1 | 668 |
| Total, serious adverse events | Placebo | 2 | 674 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rimegepant 75 mg vs Placebo: deaths from any cause | Trial comparisons |
| Rimegepant 75 mg vs Placebo: serious adverse events | 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/NCT04574362
GET https://conductscience.org/api/trials/v1/NCT04574362/results?page=2