Trial · NCT01430442

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

NCT01430442, Phase 2, Completed, Pfizer; results first posted 2020-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine. Trials, record NCT01430442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01430442

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
NCT number: NCT01430442
Status: Completed
Phases: Phase 2
Enrollment: 1,026 participants, actual
Lead sponsor: Pfizer
Conditions: Migraine, Acute Treatment of Migraine
Interventions: Rimegepant, Placebo, Sumatriptan
First posted: 2011-09-08
Last updated: 2023-02-28
Results first posted: 2020-09-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Baseline, 2 hours post-dose	Pain freedom was defined as participants reporting a value of "none" on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis.
Secondary	Number of Participants With Total Migraine Freedom at 2 Hours Post Dose	Baseline, 2 hours post dose	Total migraine freedom is defined as complete absence of migraine symptoms. A participant was positive for total migraine freedom at a particular time point if he/she reports the absence of: pain, nausea, photophobia, and phonophobia. This corresponds to reporting "none" on each of the four-point numeric rating scale (none =0, mild =1, moderate =2, severe =3) from baseline associated with these symptoms. Participants with baseline moderate pain or severe pain were included in the analysis.
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events	AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Secondary	Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose	2 hours to 24 hours post dose	Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a Cochran Mantel Haenszel (CMH) test for general association that compares the ED90 to placebo, and controls for baseline pain severity.
Secondary	Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose	2 hours to 48 hours post dose	Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a CMH test for general association that compares the ED90 to placebo, and controls for baseline pain severity.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Baseline, 2 hours post-dose	Efficacy population - all participants who took study medication with 1 post-randomization efficacy evaluation and a corresponding baseline pain evaluation for the treated headache. Participants with mild baseline pain are excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Total Migraine Freedom at 2 Hours Post Dose	Baseline, 2 hours post dose	Efficacy population - all participants who took study medication with 1 post-randomization efficacy evaluation and a corresponding baseline pain evaluation for the treated headache. Participants with Mild baseline pain are excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events	AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).	The analysis was performed on safety population, defined as all participants in the randomized population who took at least 1 capsule of study medication, as identified on the dosing record.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose	2 hours to 24 hours post dose	Efficacy population - all participants who took study medication with 1 post-randomization efficacy evaluation and a corresponding baseline pain evaluation for the treated headache. Participants with Mild baseline pain are excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose	2 hours to 48 hours post dose	Efficacy population - all participants who took study medication with 1 post-randomization efficacy evaluation and a corresponding baseline pain evaluation for the treated headache. Participants with Mild baseline pain are excluded.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment A: Rimegepant, 10 mg	14	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment B: Rimegepant, 25 mg	12	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment C: Rimegepant, 75 mg	27	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment D: Rimegepant, 150 mg	28	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment E: Rimegepant, 300 mg	33	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment F: Rimegepant, 600 mg	20	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment P: Rimegepant Placebo-Matching Capsules	31	Participants
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Treatment G: Sumatriptan 100 mg	35	Participants
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose	Treatment A: Rimegepant, 10 mg	13	Participants
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose	Treatment B: Rimegepant, 25 mg	11	Participants

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment A: Rimegepant, 10 mg	85
Overall Study	STARTED	Treatment B: Rimegepant, 25 mg	68
Overall Study	STARTED	Treatment C: Rimegepant, 75 mg	91
Overall Study	STARTED	Treatment D: Rimegepant, 150 mg	90
Overall Study	STARTED	Treatment E: Rimegepant, 300 mg	121
Overall Study	STARTED	Treatment F: Rimegepant, 600 mg	92
Overall Study	STARTED	Treatment P: Rimegepant Placebo-Matching Capsules	229
Overall Study	STARTED	Treatment G: Sumatriptan 100 mg	109
Overall Study	COMPLETED	Treatment A: Rimegepant, 10 mg	72
Overall Study	COMPLETED	Treatment B: Rimegepant, 25 mg	62

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events40

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	NAUSEA	Gastrointestinal disorders	Treatment A: Rimegepant, 10 mg	1	72	1
other	NAUSEA	Gastrointestinal disorders	Treatment B: Rimegepant, 25 mg	0	62	0
other	NAUSEA	Gastrointestinal disorders	Treatment C: Rimegepant, 75 mg	3	86	3
other	NAUSEA	Gastrointestinal disorders	Treatment D: Rimegepant, 150 mg	3	86	3
other	NAUSEA	Gastrointestinal disorders	Treatment E: Rimegepant, 300 mg	5	112	5
other	NAUSEA	Gastrointestinal disorders	Treatment F: Rimegepant, 600 mg	7	84	7
other	NAUSEA	Gastrointestinal disorders	Treatment P: Rimegepant Placebo-Matching Capsules	5	209	5
other	NAUSEA	Gastrointestinal disorders	Treatment G: Sumatriptan 100 mg	2	100	2
other	DIARRHOEA	Gastrointestinal disorders	Treatment A: Rimegepant, 10 mg	4	72	4
other	DIARRHOEA	Gastrointestinal disorders	Treatment B: Rimegepant, 25 mg	0	62	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment A: Rimegepant, 10 mg	0	85
Total, all-cause mortality	Treatment B: Rimegepant, 25 mg	0	68
Total, all-cause mortality	Treatment C: Rimegepant, 75 mg	0	91
Total, all-cause mortality	Treatment D: Rimegepant, 150 mg	0	90
Total, all-cause mortality	Treatment E: Rimegepant, 300 mg	0	121
Total, all-cause mortality	Treatment F: Rimegepant, 600 mg	0	92
Total, all-cause mortality	Treatment P: Rimegepant Placebo-Matching Capsules	0	229
Total, all-cause mortality	Treatment G: Sumatriptan 100 mg	0	109
Total, other adverse events	Treatment A: Rimegepant, 10 mg	4	72
Total, other adverse events	Treatment B: Rimegepant, 25 mg	0	62

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23965396	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01430442

GET https://conductscience.org/api/trials/v1/NCT01430442/results?page=2

API reference For AI assistants