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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01430442
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Migraine
Acute Treatment of Migraine
Interventions Drug: Rimegepant
Drug: Placebo
Drug: Sumatriptan
Enrollment 1026
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 85 68 91 90 121 92 229 109
Completed 72 62 86 86 112 84 210 100
Not Completed 13 6 5 4 9 8 19 9
Reason Not Completed
Subject Withdrew Consent             3             0             1             0             2             1             5             2
Lost to Follow-up             2             0             1             2             2             1             5             1
Pregnancy             1             0             0             0             0             1             0             0
Patient No Longer Meets Study Criteria             7             6             3             2             5             5             9             6
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 85 68 91 90 121 92 229 109 885
Hide Baseline Analysis Population Description
The analysis was performed in randomized population defined as all participants who were randomized to double-blind treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 68 participants 91 participants 90 participants 121 participants 92 participants 229 participants 109 participants 885 participants
41.1  (10.36) 36.5  (11.92) 38.5  (11.87) 39.2  (11.26) 41.9  (11.46) 39.3  (13.01) 37.9  (11.36) 40.6  (10.47) 39.3  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 68 participants 91 participants 90 participants 121 participants 92 participants 229 participants 109 participants 885 participants
Female
67
  78.8%
61
  89.7%
81
  89.0%
63
  70.0%
101
  83.5%
76
  82.6%
196
  85.6%
91
  83.5%
736
  83.2%
Male
18
  21.2%
7
  10.3%
10
  11.0%
27
  30.0%
20
  16.5%
16
  17.4%
33
  14.4%
18
  16.5%
149
  16.8%
1.Primary Outcome
Title Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
Hide Description 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.
Time Frame Baseline, 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 71 61 86 85 111 82 203 100
Measure Type: Count of Participants
Unit of Measure: Participants
14
  19.7%
12
  19.7%
27
  31.4%
28
  32.9%
33
  29.7%
20
  24.4%
31
  15.3%
35
  35.0%
2.Secondary Outcome
Title Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
Hide Description 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.
Time Frame Baseline, 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 71 61 86 85 111 82 203 100
Measure Type: Count of Participants
Unit of Measure: Participants
13
  18.3%
11
  18.0%
24
  27.9%
22
  25.9%
26
  23.4%
16
  19.5%
24
  11.8%
32
  32.0%
3.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 72 62 86 86 112 84 209 100
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
15
  20.8%
10
  16.1%
18
  20.9%
12
  14.0%
18
  16.1%
14
  16.7%
29
  13.9%
17
  17.0%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
3
   3.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Participants discontinued due to AEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
Hide Description 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.
Time Frame 2 hours to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 71 61 86 85 111 82 203 100
Measure Type: Count of Participants
Unit of Measure: Participants
9
  12.7%
10
  16.4%
24
  27.9%
24
  28.2%
29
  26.1%
17
  20.7%
15
   7.4%
26
  26.0%
5.Secondary Outcome
Title Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
Hide Description 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.
Time Frame 2 hours to 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 71 61 86 85 111 82 203 100
Measure Type: Count of Participants
Unit of Measure: Participants
8
  11.3%
9
  14.8%
24
  27.9%
24
  28.2%
29
  26.1%
17
  20.7%
15
   7.4%
26
  26.0%
Time Frame 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)
Adverse Event Reporting Description 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.
 
Arm/Group Title Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)      0/68 (0.00%)      0/91 (0.00%)      0/90 (0.00%)      0/121 (0.00%)      0/92 (0.00%)      0/229 (0.00%)      0/109 (0.00%)    
Hide Serious Adverse Events
Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/72 (0.00%)      0/62 (0.00%)      0/86 (0.00%)      03/86 (3.49%)      0/112 (0.00%)      0/84 (0.00%)      0/209 (0.00%)      0/100 (0.00%)    
Cardiac disorders                 
STRESS CARDIOMYOPATHY  1  0/72 (0.00%)  0 0/62 (0.00%)  0 0/86 (0.00%)  0 1/86 (1.16%)  1 0/112 (0.00%)  0 0/84 (0.00%)  0 0/209 (0.00%)  0 0/100 (0.00%)  0
Infections and infestations                 
PNEUMONIA  1  0/72 (0.00%)  0 0/62 (0.00%)  0 0/86 (0.00%)  0 1/86 (1.16%)  1 0/112 (0.00%)  0 0/84 (0.00%)  0 0/209 (0.00%)  0 0/100 (0.00%)  0
Injury, poisoning and procedural complications                 
POST LUMBAR PUNCTURE SYNDROME  1  0/72 (0.00%)  0 0/62 (0.00%)  0 0/86 (0.00%)  0 1/86 (1.16%)  1 0/112 (0.00%)  0 0/84 (0.00%)  0 0/209 (0.00%)  0 0/100 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A: Rimegepant, 10 mg Treatment B: Rimegepant, 25 mg Treatment C: Rimegepant, 75 mg Treatment D: Rimegepant, 150 mg Treatment E: Rimegepant, 300 mg Treatment F: Rimegepant, 600 mg Treatment P: Rimegepant Placebo-Matching Capsules Treatment G: Sumatriptan 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/72 (5.56%)      0/62 (0.00%)      3/86 (3.49%)      3/86 (3.49%)      6/112 (5.36%)      7/84 (8.33%)      5/209 (2.39%)      2/100 (2.00%)    
Gastrointestinal disorders                 
NAUSEA  1  1/72 (1.39%)  1 0/62 (0.00%)  0 3/86 (3.49%)  3 3/86 (3.49%)  3 5/112 (4.46%)  5 7/84 (8.33%)  7 5/209 (2.39%)  5 2/100 (2.00%)  2
DIARRHOEA  1  4/72 (5.56%)  4 0/62 (0.00%)  0 0/86 (0.00%)  0 0/86 (0.00%)  0 1/112 (0.89%)  1 0/84 (0.00%)  0 0/209 (0.00%)  0 0/100 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Biohaven Pharmaceuticals, Inc.
Phone: 203-404-0410
EMail: clinicaltrials@biohavenpharma.com
Layout table for additonal information
Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01430442    
Other Study ID Numbers: CN170-003
First Submitted: September 7, 2011
First Posted: September 8, 2011
Results First Submitted: August 5, 2020
Results First Posted: September 3, 2020
Last Update Posted: September 3, 2020