Trial Outcomes & Findings for Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine (NCT NCT01430442)
NCT ID: NCT01430442
Last Updated: 2023-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1026 participants
Primary outcome timeframe
Baseline, 2 hours post-dose
Results posted on
2023-02-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
68
|
91
|
90
|
121
|
92
|
229
|
109
|
|
Overall Study
COMPLETED
|
72
|
62
|
86
|
86
|
112
|
84
|
210
|
100
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
5
|
4
|
9
|
8
|
19
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Subject Withdrew Consent
|
3
|
0
|
1
|
0
|
2
|
1
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
2
|
2
|
1
|
5
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient No Longer Meets Study Criteria
|
7
|
6
|
3
|
2
|
5
|
5
|
9
|
6
|
Baseline Characteristics
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Treatment A: Rimegepant, 10 mg
n=85 Participants
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.
|
Treatment B: Rimegepant, 25 mg
n=68 Participants
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
n=91 Participants
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
n=90 Participants
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.
|
Treatment E: Rimegepant, 300 mg
n=121 Participants
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
n=92 Participants
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
n=229 Participants
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
n=109 Participants
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.
|
Total
n=885 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.36 • n=99 Participants
|
36.5 years
STANDARD_DEVIATION 11.92 • n=107 Participants
|
38.5 years
STANDARD_DEVIATION 11.87 • n=206 Participants
|
39.2 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 11.46 • n=31 Participants
|
39.3 years
STANDARD_DEVIATION 13.01 • n=30 Participants
|
37.9 years
STANDARD_DEVIATION 11.36 • n=3 Participants
|
40.6 years
STANDARD_DEVIATION 10.47 • n=6 Participants
|
39.3 years
STANDARD_DEVIATION 11.52 • n=114 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
101 Participants
n=31 Participants
|
76 Participants
n=30 Participants
|
196 Participants
n=3 Participants
|
91 Participants
n=6 Participants
|
736 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
33 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
149 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Rimegepant, 10 mg
n=71 Participants
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.
|
Treatment B: Rimegepant, 25 mg
n=61 Participants
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
n=86 Participants
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
n=85 Participants
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.
|
Treatment E: Rimegepant, 300 mg
n=111 Participants
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
n=82 Participants
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
n=203 Participants
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
n=100 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
|
14 Participants
|
12 Participants
|
27 Participants
|
28 Participants
|
33 Participants
|
20 Participants
|
31 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2 hours post dosePopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Rimegepant, 10 mg
n=71 Participants
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.
|
Treatment B: Rimegepant, 25 mg
n=61 Participants
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
n=86 Participants
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
n=85 Participants
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.
|
Treatment E: Rimegepant, 300 mg
n=111 Participants
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
n=82 Participants
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
n=203 Participants
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
n=100 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
|
13 Participants
|
11 Participants
|
24 Participants
|
22 Participants
|
26 Participants
|
16 Participants
|
24 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Treatment A: Rimegepant, 10 mg
n=72 Participants
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.
|
Treatment B: Rimegepant, 25 mg
n=62 Participants
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
n=86 Participants
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
n=86 Participants
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.
|
Treatment E: Rimegepant, 300 mg
n=112 Participants
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
n=84 Participants
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
n=209 Participants
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
n=100 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
AEs
|
15 Participants
|
10 Participants
|
18 Participants
|
12 Participants
|
18 Participants
|
14 Participants
|
29 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
Participants discontinued due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours to 24 hours post dosePopulation: 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 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.
Outcome measures
| Measure |
Treatment A: Rimegepant, 10 mg
n=71 Participants
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.
|
Treatment B: Rimegepant, 25 mg
n=61 Participants
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
n=86 Participants
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
n=85 Participants
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.
|
Treatment E: Rimegepant, 300 mg
n=111 Participants
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
n=82 Participants
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
n=203 Participants
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
n=100 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
|
9 Participants
|
10 Participants
|
24 Participants
|
24 Participants
|
29 Participants
|
17 Participants
|
15 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 2 hours to 48 hours post dosePopulation: 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 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.
Outcome measures
| Measure |
Treatment A: Rimegepant, 10 mg
n=71 Participants
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.
|
Treatment B: Rimegepant, 25 mg
n=61 Participants
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
n=86 Participants
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
n=85 Participants
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.
|
Treatment E: Rimegepant, 300 mg
n=111 Participants
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
n=82 Participants
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
n=203 Participants
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
n=100 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
|
8 Participants
|
9 Participants
|
24 Participants
|
24 Participants
|
29 Participants
|
17 Participants
|
15 Participants
|
26 Participants
|
Adverse Events
Treatment A: Rimegepant, 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment B: Rimegepant, 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment C: Rimegepant, 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment D: Rimegepant, 150 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment E: Rimegepant, 300 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment F: Rimegepant, 600 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment P: Rimegepant Placebo-Matching Capsules
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment G: Sumatriptan 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A: Rimegepant, 10 mg
n=72 participants at risk
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.
|
Treatment B: Rimegepant, 25 mg
n=62 participants at risk
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
n=86 participants at risk
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
n=86 participants at risk
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.
|
Treatment E: Rimegepant, 300 mg
n=112 participants at risk
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
n=84 participants at risk
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
n=209 participants at risk
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
n=100 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/72 • 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.
|
0.00%
0/62 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/112 • 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.
|
0.00%
0/84 • 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.
|
0.00%
0/209 • 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.
|
0.00%
0/100 • 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.
|
|
Injury, poisoning and procedural complications
POST LUMBAR PUNCTURE SYNDROME
|
0.00%
0/72 • 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.
|
0.00%
0/62 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/112 • 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.
|
0.00%
0/84 • 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.
|
0.00%
0/209 • 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.
|
0.00%
0/100 • 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.
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/72 • 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.
|
0.00%
0/62 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/112 • 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.
|
0.00%
0/84 • 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.
|
0.00%
0/209 • 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.
|
0.00%
0/100 • 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.
|
Other adverse events
| Measure |
Treatment A: Rimegepant, 10 mg
n=72 participants at risk
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.
|
Treatment B: Rimegepant, 25 mg
n=62 participants at risk
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
n=86 participants at risk
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
n=86 participants at risk
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.
|
Treatment E: Rimegepant, 300 mg
n=112 participants at risk
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
n=84 participants at risk
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
n=209 participants at risk
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
n=100 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
1.4%
1/72 • Number of events 1 • 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.
|
0.00%
0/62 • 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.
|
3.5%
3/86 • Number of events 3 • 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.
|
3.5%
3/86 • Number of events 3 • 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.
|
4.5%
5/112 • Number of events 5 • 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.
|
8.3%
7/84 • Number of events 7 • 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.
|
2.4%
5/209 • Number of events 5 • 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.
|
2.0%
2/100 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.6%
4/72 • Number of events 4 • 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.
|
0.00%
0/62 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/86 • 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.
|
0.89%
1/112 • Number of events 1 • 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.
|
0.00%
0/84 • 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.
|
0.00%
0/209 • 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.
|
0.00%
0/100 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60