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The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.
Intervention Model: Parallel Versus Comparator + Placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Rimegepant, 10 mg | Experimental | Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
|
| Treatment B: Rimegepant, 25 mg | Experimental | Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
|
| Treatment C: Rimegepant, 75 mg | Experimental | Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
|
| Treatment D: Rimegepant, 150 mg | Experimental | Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pain Free Participants (Pain Freedom) at 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. | Baseline, 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Total Migraine Freedom at 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. |
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Key Inclusion Criteria:
Patient with at least 1-year history of migraines (with or without aura) including the following:
Male and female ≥ 18 years and ≤ age 65
No clinically significant abnormality identified on the medical or laboratory evaluation
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Clinical Res. Advantage Inc/ Desert Clinical Research Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23965396 | Derived | Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21. |
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The study was divided into 3 phases: a screening/baseline phase (3-28 days), an acute treatment phase (up to 45 days during which participants were treated on 1 migraine headache of moderate to severe intensity), followed by an end-of-treatment visit within 7 days of administration of study drug.
The study was conducted at 41 centers in the United States. A total of 1026 participants were enrolled in the study, and 885 of these were randomized to treatment. Of the 141 participants who were not randomized, the main reason for non-randomization was participants no longer met inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A: Rimegepant, 10 mg | Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Treatment E: Rimegepant, 300 mg | Experimental | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
|
| Treatment F: Rimegepant, 600 mg | Experimental | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
|
| Treatment P: Rimegepant Placebo-Matching Capsules | Placebo Comparator | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
|
| Treatment G: Sumatriptan 100 mg | Active Comparator | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
|
| Placebo | Drug | Rimegepant placebo-matching capsules |
|
| Sumatriptan | Drug | Rimegepant matching sumatriptan and Rimegepant matching placebo capsules |
|
|
| Baseline, 2 hours post dose |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events | 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. | 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). |
| Number of Participants Achieving Sustained Pain Freedom From 2 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. | 2 hours to 24 hours post dose |
| Number of Participants Achieving Sustained Pain Freedom From 2 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. | 2 hours to 48 hours post dose |
| Tempe |
| Arizona |
| 85282 |
| United States |
| University Of California, San Francisco | San Francisco | California | 94115 | United States |
| California Medical Clinic For Headache | Santa Monica | California | 90404 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Radiant Research, Inc. | Denver | Colorado | 80239 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Broward Research Group | Pembroke Pines | Florida | 33026 | United States |
| Comprehensive Clinical Development, Inc | St. Petersburg | Florida | 33716 | United States |
| Diamond Headache Clinic, Ltd. | Chicago | Illinois | 60642 | United States |
| Milford Emergency Associates, Inc. | Milford | Massachusetts | 01757 | United States |
| Medvadis Research Corporation | Watertown | Massachusetts | 02472-3930 | United States |
| Michigan Head Pain And Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| The Center For Pharmaceutical Research. Pc | Kansas City | Missouri | 64114 | United States |
| Clinvest/ A Division Of Banyan Group, Inc. | Springfield | Missouri | 65807 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Regional Clinical Research Inc. | Endwell | New York | 13760 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Pharmquest | Greensboro | North Carolina | 27408 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Pmg Research Of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Research Of Philadelphia, Llc | Philadelphia | Pennsylvania | 19114 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Coastal Carolina Research Center, Inc. | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinsearch, Llc | Chattanooga | Tennessee | 37421 | United States |
| Premier Research Group Limited | Austin | Texas | 78705 | United States |
| Futuresearch Trials Of Neurology | Austin | Texas | 78731 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| J. Lewis Research, Inc | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc | Salt Lake City | Utah | 84121 | United States |
| The Innovative Clinical Research Center | Alexandria | Virginia | 22304 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | United States |
| Swedish Pain And Headache Center | Seattle | Washington | 98104 | United States |
| Treatment B: Rimegepant, 25 mg |
Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| FG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| FG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| FG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| FG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| FG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| FG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis was performed in randomized population defined as all participants who were randomized to double-blind treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A: Rimegepant, 10 mg | Participants received a single dose (one capsule) of rimegepant 10 mg orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| BG001 | Treatment B: Rimegepant, 25 mg | Participants received a single dose (one capsule) of rimegepant 25 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| BG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| BG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| BG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| BG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| BG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| BG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| BG008 | 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Number of Pain Free Participants (Pain Freedom) at 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. | 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. | Posted | Count of Participants | Participants | Baseline, 2 hours post-dose |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Total Migraine Freedom at 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. | 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. | Posted | Count of Participants | Participants | Baseline, 2 hours post dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events | 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. | 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. | Posted | Count of Participants | Participants | 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). |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Sustained Pain Freedom From 2 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. | 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. | Posted | Count of Participants | Participants | 2 hours to 24 hours post dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Sustained Pain Freedom From 2 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. | 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. | Posted | Count of Participants | Participants | 2 hours to 48 hours post dose |
|
AEs: from first dose to end of treatment visit (up to 52 days); SAE: from signing of informed consent to 30 days after the last dose (up to 80 days)
All-Cause Mortality based on randomized population. SAEs and Other AEs based 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.
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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 | Treatment A: Rimegepant, 10 mg | Participants received a single dose (one capsule) of rimegepant 10 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. | 0 | 85 | 0 | 72 | 4 | 72 |
| EG001 | Treatment B: Rimegepant, 25 mg | Participants received a single dose (one capsule) of rimegepant 25 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. | 0 | 68 | 0 | 62 | 0 | 62 |
| EG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. | 0 | 91 | 0 | 86 | 3 | 86 |
| EG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. | 0 | 90 | 3 | 86 | 3 | 86 |
| EG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. | 0 | 121 | 0 | 112 | 6 | 112 |
| EG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. | 0 | 92 | 0 | 84 | 7 | 84 |
| EG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. | 0 | 229 | 0 | 209 | 5 | 209 |
| EG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. | 0 | 109 | 0 | 100 | 2 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONIA | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| POST LUMBAR PUNCTURE SYNDROME | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Biohaven Pharmaceuticals, Inc. | 203-404-0410 | clinicaltrials@biohavenpharma.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| OG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| OG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
|
|
Participants received a single dose (one capsule) of rimegepant 25 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| OG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
|
|
| OG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| OG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
|
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| OG002 | Treatment C: Rimegepant, 75 mg | Participants received a single dose (one capsule) of rimegepant 75 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG003 | Treatment D: Rimegepant, 150 mg | Participants received a single dose (one capsule) of rimegepant 150 mg orally, and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG004 | Treatment E: Rimegepant, 300 mg | Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG005 | Treatment F: Rimegepant, 600 mg | Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. |
| OG006 | Treatment P: Rimegepant Placebo-Matching Capsules | Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
| OG007 | Treatment G: Sumatriptan 100 mg | Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. |
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