Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial in Adult Subjects With Acute Migraines

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: NCT03461757
Recruitment Status : Completed
First Posted : March 12, 2018
Results First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Migraine, With or Without Aura
Interventions Drug: Rimegepant
Drug: Placebo
Enrollment 1811
Recruitment Details The study was conducted at 69 centers in the United States.
Pre-assignment Details Total 1811 participants were enrolled, of which 1466 were randomized to rimegepant 75 milligram (mg) orally disintegrating tablet (ODT) or placebo. Total 345 participants failed screening mainly due to failure to meet eligibility criteria. Randomization was stratified in 1:1 ratio based on use of prophylactic migraine medications (yes or no).
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Period Title: Overall Study
Started 732 734
Treated 682 693
Completed 679 689
Not Completed 53 45
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             13             7
Not Experienced Moderate/Severe Migraine             28             25
Non-compliance with study treatment             0             1
Pregnancy             2             0
Protocol Violation             1             1
Withdrawal by Subject             7             7
Other Reasons             1             4
Arm/Group Title Rimegepant 75 mg ODT Placebo Total
Hide Arm/Group Description Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. Total of all reporting groups
Overall Number of Baseline Participants 669 682 1351
Hide Baseline Analysis Population Description
The analysis was performed on modified intent to treat (mITT) participants, defined as those who were randomized only once, took study medication, had moderate to severe pain level at migraine onset, and who provided at least 1 post-baseline efficacy measurement (i.e., after taking study medication).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 669 participants 682 participants 1351 participants
40.287  (12.0792) 40.030  (11.8719) 40.157  (11.9713)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 669 participants 682 participants 1351 participants
Female
568
  84.9%
579
  84.9%
1147
  84.9%
Male
101
  15.1%
103
  15.1%
204
  15.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 669 participants 682 participants 1351 participants
Hispanic or Latino
116
  17.3%
135
  19.8%
251
  18.6%
Not Hispanic or Latino
553
  82.7%
547
  80.2%
1100
  81.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 669 participants 682 participants 1351 participants
American Indian or Alaska Native
4
   0.6%
3
   0.4%
7
   0.5%
Asian
8
   1.2%
19
   2.8%
27
   2.0%
Native Hawaiian or Other Pacific Islander
141
  21.1%
125
  18.3%
266
  19.7%
Black or African American
11
   1.6%
5
   0.7%
16
   1.2%
White
496
  74.1%
521
  76.4%
1017
  75.3%
More than one race
7
   1.0%
9
   1.3%
16
   1.2%
Unknown or Not Reported
2
   0.3%
0
   0.0%
2
   0.1%
Primary Migraine Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 669 participants 682 participants 1351 participants
Migraine without Aura
480
  71.7%
462
  67.7%
942
  69.7%
Migraine with Aura
189
  28.3%
220
  32.3%
409
  30.3%
Randomization Strata, Prophylactic Migraine Medication Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 669 participants 682 participants 1351 participants
Yes
93
  13.9%
94
  13.8%
187
  13.8%
No
576
  86.1%
588
  86.2%
1164
  86.2%
1.Primary Outcome
Title Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on modified intent to treat (mITT) participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.2
(18.1 to 24.3)
10.9
(8.5 to 13.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
6.5 to 14.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Hide Description MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.1
(31.5 to 38.7)
26.8
(23.5 to 30.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.3
Confidence Interval (2-Sided) 95%
3.4 to 13.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Pain Relief at 2 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59.3
(55.6 to 63.1)
43.3
(39.5 to 47.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.1
Confidence Interval (2-Sided) 95%
10.8 to 21.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
Hide Description Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.1
(34.4 to 41.8)
25.8
(22.5 to 29.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
15.1 to 25.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
Time Frame From 2 hours up to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.8
(44.0 to 51.6)
27.7
(24.4 to 31.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
15.1 to 25.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose
Hide Description MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
Time Frame From 2 hours up to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.1
(23.7 to 30.4)
17.7
(14.9 to 20.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
4.9 to 13.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Hide Description Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.2
(11.6 to 16.8)
29.2
(25.8 to 32.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -15.0
Confidence Interval (2-Sided) 95%
-19.3 to -10.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose
Hide Description Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
Time Frame From 2 hours up to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.6
(26.1 to 33.1)
16.9
(14.1 to 19.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
8.3 to 17.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
Time Frame From 2 hours up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.2
(38.4 to 45.9)
25.2
(22.0 to 28.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.9
Confidence Interval (2-Sided) 95%
12.0 to 21.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose
Hide Description MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
Time Frame From 2 hours up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.2
(20.0 to 26.4)
16.4
(13.6 to 19.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
2.5 to 11.0
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose
Hide Description Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
Time Frame From 2 hours up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.0
(22.7 to 29.3)
15.4
(12.7 to 18.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.6
Confidence Interval (2-Sided) 95%
6.3 to 14.9
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Hide Description Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants with photophobia present at migraine onset.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 593 611
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.4
(29.6 to 37.2)
24.5
(21.1 to 28.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
3.7 to 13.9
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose
Hide Description Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.
Time Frame 90 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.2
(26.7 to 33.7)
21.3
(18.2 to 24.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.9
Confidence Interval (2-Sided) 95%
4.3 to 13.6
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Pain Relief at 90 Minutes Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.
Time Frame 90 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.6
(45.8 to 53.4)
37.2
(33.6 to 40.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
7.1 to 17.6
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
Time Frame From 2 hours up to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.7
(12.9 to 18.4)
5.6
(3.9 to 7.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.1
Confidence Interval (2-Sided) 95%
6.9 to 13.4
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose
Hide Description MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.
Time Frame 90 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.4
(24.0 to 30.7)
21.5
(18.5 to 24.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0128
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
1.2 to 10.4
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.
Time Frame 90 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.1
(12.4 to 17.8)
7.3
(5.4 to 9.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
4.4 to 11.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Hide Description Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants with phonophobia present at migraine onset.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 451 447
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.7
(37.2 to 46.3)
30.2
(25.9 to 34.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.5
Confidence Interval (2-Sided) 95%
5.3 to 17.7
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
Time Frame From 2 hours up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.5
(10.9 to 16.0)
5.4
(3.7 to 7.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
4.9 to 11.1
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With Pain Relief at 60 Minutes Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.
Time Frame 60 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.8
(33.1 to 40.4)
31.2
(27.8 to 34.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0314
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
0.5 to 10.6
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose
Hide Description Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.
Time Frame 60 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 669 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.3
(19.1 to 25.4)
15.8
(13.1 to 18.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
2.3 to 10.6
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Hide Description Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on mITT participants with nausea present at migraine onset.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 397 430
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.0
(46.1 to 55.9)
45.2
(40.5 to 49.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rimegepant 75 mg ODT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0898
Comments P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.9
Confidence Interval (2-Sided) 95%
-0.9 to 12.7
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
Hide Description Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose for the participants who were pain-free at 2 hours post-dose.
Time Frame From 2 hours up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was performed on mITT participants with pain freedom at 2 hours post-dose.
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description:
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Overall Number of Participants Analyzed 142 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.6
(28.7 to 44.5)
50.0
(38.7 to 61.2)
Time Frame Serious adverse events (SAEs) were collected from informed consent up to the end of the study, and adverse events (AEs) were collected from randomization up to end of the study (up to 52 days).
Adverse Event Reporting Description The safety population, all enrolled participants who received at least 1 dose of rimegepant or placebo, was used to determine the number of participants at risk for SAEs and Other AEs.
 
Arm/Group Title Rimegepant 75 mg ODT Placebo
Hide Arm/Group Description Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
All-Cause Mortality
Rimegepant 75 mg ODT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/682 (0.00%)   0/693 (0.00%) 
Hide Serious Adverse Events
Rimegepant 75 mg ODT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/682 (0.00%)   0/693 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rimegepant 75 mg ODT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/682 (0.00%)   0/693 (0.00%) 
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: NCT03461757    
Other Study ID Numbers: BHV3000-303
First Submitted: March 6, 2018
First Posted: March 12, 2018
Results First Submitted: March 12, 2020
Results First Posted: March 27, 2020
Last Update Posted: March 27, 2020