Open Label Safety Study in Acute Treatment of Migraine
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Rimegepant
|
Drug: Rimegepant
75 mg oral tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period [PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks]
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.
- Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period [PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks]
Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for Glucose, LDL-Cholesterol, Uric Acid, and Urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the on-treatment period to be included for a given parameter.
Secondary Outcome Measures
- Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period [PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks]
Elevations of on-treatment AST or ALT > 3 x ULN concurrent with total bilirubin > 2 x ULN were defined as elevations on the same collection date.
- Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period [PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks]
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation patient administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Hepatic AEs were defined as all on-treatment PTs under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those PTs in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Subjects with 2-8 moderate to severe migraines/month
-
Age of onset of migraines prior to 50 years of age
-
Migraine attacks, on average, lasting 4-72 hours if untreated
-
Ability to distinguish migraine attacks from tension/cluster headaches
-
Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria
Key Exclusion Criteria:
-
History of basilar migraine or hemiplegic migraine
-
History of HIV disease
-
History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.
-
Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening
-
History of gastric or small intestinal surgery or has a disease that causes malabsorption
-
BMI ≥ 30
-
HbA1c ≥ 6.5%
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Central Research Associates, Inc | Birmingham | Alabama | United States | 35205 |
2 | Coastal Clinical Research, Inc. | Mobile | Alabama | United States | 36608 |
3 | Thunderbird Internal Medicine / Radiant Research, Inc | Glendale | Arizona | United States | 85306 |
4 | Neurological Physicians of Arizona | Tempe | Arizona | United States | 85202 |
5 | Clinical Research Consortium Arizona | Tempe | Arizona | United States | 85283 |
6 | Woodland International Research Group, LLC | Little Rock | Arkansas | United States | 72211 |
7 | Woodland Research Northwest, LLC | Rogers | Arkansas | United States | 72758 |
8 | Pharmacology Research Institute | Encino | California | United States | 91316 |
9 | eStudySite | La Mesa | California | United States | 91942 |
10 | Collaborative Neuroscience Network, LLC | Long Beach | California | United States | 90806 |
11 | Pharmacology Research Institute | Los Alamitos | California | United States | 90720 |
12 | Pharmacology Research Institute | Newport Beach | California | United States | 92660 |
13 | Pacific Research Partners LLC | Oakland | California | United States | 94607 |
14 | National Research Institute | Panorama City | California | United States | 91402 |
15 | Optimus Medical Group | San Francisco | California | United States | 94102 |
16 | California Medical Clinic for Headache | Santa Monica | California | United States | 90404 |
17 | California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | United States | 91403 |
18 | Diablo Clinical Research, Inc | Walnut Creek | California | United States | 94598 |
19 | Clinical Trials of the Rockies | Denver | Colorado | United States | 80209 |
20 | AGA Clinical Trials | Hialeah | Florida | United States | 33012 |
21 | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | United States | 32256 |
22 | Multi-Specialty Research Associates, Inc | Lake City | Florida | United States | 32055 |
23 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
24 | Clinical Neuroscience Solutions, Inc | Orlando | Florida | United States | 32801 |
25 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
26 | Ormond Medical Arts Pharmaceutical Research | Ormond Beach | Florida | United States | 32174 |
27 | Meridien Research | Tampa | Florida | United States | 33634 |
28 | Radiant Research, Inc. | Atlanta | Georgia | United States | 30328 |
29 | Meridian Clinical Research | Savannah | Georgia | United States | 31406 |
30 | Savannah Neurology Specialists | Savannah | Georgia | United States | 31406 |
31 | Christie Clinic, LLC | Champaign | Illinois | United States | 61820 |
32 | PMG Research of McFrland Clinic | Ames | Iowa | United States | 50010 |
33 | Heartland Research Associates, LLC | Augusta | Kansas | United States | 67010 |
34 | Heartland Research Associates, LLC | Newton | Kansas | United States | 67114 |
35 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67205 |
36 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
37 | Benchmark Research | Metairie | Louisiana | United States | 70006 |
38 | MedPharmics, LLC | Metairie | Louisiana | United States | 70006 |
39 | New Orleans Center for Clinical Research | New Orleans | Louisiana | United States | 70119 |
40 | Boston Clinical Trials, Inc. | Boston | Massachusetts | United States | 02131 |
41 | NECCR Primacare Research, LLC | Fall River | Massachusetts | United States | 02721 |
42 | Milford Emergency Associates, Inc. | Marlborough | Massachusetts | United States | 01752 |
43 | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | United States | 48104 |
44 | Clinical Research Institute, Inc. | Minneapolis | Minnesota | United States | 55402 |
45 | Clinical Research Insitute | Plymouth | Minnesota | United States | 55441 |
46 | The Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
47 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
48 | Meridian Clinical Research -Norfolk | Norfolk | Nebraska | United States | 68701 |
49 | Meridian Clinical Research, LLC | Omaha | Nebraska | United States | 68134 |
50 | Clinical Research Consortium- Las Vegas | Las Vegas | Nevada | United States | 89119 |
51 | Hassman Research Institute, LLC | Berlin | New Jersey | United States | 08009 |
52 | Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | United States | 87109 |
53 | United Medical Associates | Binghamton | New York | United States | 13901 |
54 | Montefiore Heachache Center | Bronx | New York | United States | 10461 |
55 | SPRI Clinical Trials, LLC | Brooklyn | New York | United States | 11235 |
56 | Regional Clinical Research, Inc. | Endwell | New York | United States | 13760 |
57 | Radiant Research, Inc. | Jamaica | New York | United States | 11432 |
58 | Central New York Clinical Research | Manlius | New York | United States | 13104 |
59 | Fieve Clinical Research | New York | New York | United States | 10168 |
60 | Rochester Clinical Research, Inc | Rochester | New York | United States | 14609 |
61 | PMG Research of Charlotte, LLC | Charlotte | North Carolina | United States | 28209 |
62 | PharmQuest, LLC | Greensboro | North Carolina | United States | 27408 |
63 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27609 |
64 | Wake Research Associates, LLC | Raleigh | North Carolina | United States | 27612 |
65 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
66 | CTI Clinical Research Center | Cincinnati | Ohio | United States | 45227 |
67 | Radiant Research, Inc. | Cincinnati | Ohio | United States | 45236 |
68 | Radiant Research, Inc. | Columbus | Ohio | United States | 43212 |
69 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
70 | Neurology Diagnostics, Inc. | Dayton | Ohio | United States | 45459 |
71 | Aventiv Research, Inc. | Dublin | Ohio | United States | 43016 |
72 | Summit Research Network (Oregon), Inc. | Portland | Oregon | United States | 97210 |
73 | Oregon Center for Clinical Investigations, Inc | Salem | Oregon | United States | 97301 |
74 | Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | United States | 19114 |
75 | Fieve Clinical Research | Scranton | Pennsylvania | United States | 18503 |
76 | Preferred Primary Care Physicians | Uniontown | Pennsylvania | United States | 15401 |
77 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
78 | Radiant Research, Inc. | Anderson | South Carolina | United States | 29621 |
79 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
80 | Meridian Clinical Research | Dakota Dunes | South Dakota | United States | 57049 |
81 | PMG Research of Bristol, LLC | Bristol | Tennessee | United States | 37620 |
82 | Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | United States | 38119 |
83 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
84 | FutureSearch Trials of Neurology, LP | Austin | Texas | United States | 78731 |
85 | Tekton Research- Austin | Austin | Texas | United States | 78745 |
86 | FutureSearch Trials of Neurology, LP | Dallas | Texas | United States | 75231 |
87 | Ventavia Research Group, LLC | Fort Worth | Texas | United States | 76104 |
88 | Texas Center for Drug Development | Houston | Texas | United States | 77081 |
89 | Red Star Research, LLC | Lake Jackson | Texas | United States | 77566 |
90 | FMC Science | Lampasas | Texas | United States | 76550 |
91 | PCP for Life | Magnolia | Texas | United States | 77355 |
92 | Research Across America - Mesquite | Mesquite | Texas | United States | 75149 |
93 | Doctors of Internal Medicine, LTD / Radiant Research Inc. | Plano | Texas | United States | 75093 |
94 | DM Clinical Research | Tomball | Texas | United States | 77375 |
95 | J.Lewis Research Inc / Foothill Family Clinic South | Salt Lake City | Utah | United States | 84121 |
96 | Tidewater Integrated Medical Research | Virginia Beach | Virginia | United States | 23454 |
97 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
98 | Seattle Women's:Health, Research & Gynecology | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Biohaven Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- BHV3000-201
Study Results
Participant Flow
Recruitment Details | The study was conducted at 103 centers in the United States. |
---|---|
Pre-assignment Detail | A total of 3019 participants were screened for this open-label study. A total of 2867 participants entered the observational period, and 1908 participants subsequently enrolled in the long-term treatment period of whom 1800 received treatment. A total of 807 participants failed screening mainly due to failure to meet eligibility criteria. |
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
---|---|---|---|
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. |
Period Title: Observational Period | |||
STARTED | 1605 | 786 | 476 |
COMPLETED | 1089 | 511 | 308 |
NOT COMPLETED | 516 | 275 | 168 |
Period Title: Observational Period | |||
STARTED | 1089 | 511 | 308 |
Treated | 1033 | 481 | 286 |
COMPLETED | 683 | 271 | 243 |
NOT COMPLETED | 406 | 240 | 65 |
Baseline Characteristics
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | Total |
---|---|---|---|---|
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. | Total of all reporting groups |
Overall Participants | 1033 | 481 | 286 | 1800 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
44.0
(11.79)
|
42.4
(12.41)
|
41.1
(12.69)
|
43.1
(12.15)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
917
88.8%
|
444
92.3%
|
248
86.7%
|
1609
89.4%
|
Male |
116
11.2%
|
37
7.7%
|
38
13.3%
|
191
10.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
99
9.6%
|
54
11.2%
|
24
8.4%
|
177
9.8%
|
Not Hispanic or Latino |
934
90.4%
|
427
88.8%
|
262
91.6%
|
1623
90.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
4
0.4%
|
4
0.8%
|
2
0.7%
|
10
0.6%
|
Asian |
16
1.5%
|
7
1.5%
|
9
3.1%
|
32
1.8%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
3
0.6%
|
2
0.7%
|
5
0.3%
|
Black or African American |
149
14.4%
|
66
13.7%
|
35
12.2%
|
250
13.9%
|
White |
847
82%
|
394
81.9%
|
234
81.8%
|
1475
81.9%
|
More than one race |
17
1.6%
|
7
1.5%
|
4
1.4%
|
28
1.6%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | ||||
United States |
1033
100%
|
481
100%
|
286
100%
|
1800
100%
|
Outcome Measures
Title | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period |
---|---|
Description | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. |
Time Frame | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed on treated participants. |
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
---|---|---|---|
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. |
Measure Participants | 1033 | 481 | 286 |
Overall number of participants with at least 1 AE |
664
64.3%
|
315
65.5%
|
109
38.1%
|
AE ≥5%-Upper respiratory tract infection |
108
10.5%
|
38
7.9%
|
12
4.2%
|
Mild-Upper respiratory tract infection |
56
5.4%
|
21
4.4%
|
8
2.8%
|
Moderate-Upper respiratory tract infection |
51
4.9%
|
17
3.5%
|
4
1.4%
|
Severe-Upper respiratory tract infection |
1
0.1%
|
0
0%
|
0
0%
|
AE ≥5%-Nasopharyngitis |
72
7%
|
41
8.5%
|
9
3.1%
|
Mild-Nasopharyngitis |
53
5.1%
|
28
5.8%
|
7
2.4%
|
Moderate-Nasopharyngitis |
19
1.8%
|
13
2.7%
|
2
0.7%
|
AE ≥5%-Sinusitis |
57
5.5%
|
28
5.8%
|
7
2.4%
|
Mild-Sinusitis |
26
2.5%
|
19
4%
|
5
1.7%
|
Moderate-Sinusitis |
30
2.9%
|
9
1.9%
|
2
0.7%
|
Severe-Sinusitis |
1
0.1%
|
0
0%
|
0
0%
|
SAEs |
28
2.7%
|
16
3.3%
|
3
1%
|
AEs leading to discontinuation |
24
2.3%
|
16
3.3%
|
8
2.8%
|
Title | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period |
---|---|
Description | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for Glucose, LDL-Cholesterol, Uric Acid, and Urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the on-treatment period to be included for a given parameter. |
Time Frame | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed on treated participants. |
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
---|---|---|---|
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. |
Measure Participants | 1033 | 481 | 286 |
Alanine Aminotransferase (ALT) |
3
0.3%
|
2
0.4%
|
0
0%
|
Aspartate Aminotransferase (AST) |
4
0.4%
|
2
0.4%
|
0
0%
|
Albumin |
0
0%
|
0
0%
|
0
0%
|
Alkaline Phosphatase |
0
0%
|
0
0%
|
0
0%
|
Bicarbonate |
0
0%
|
0
0%
|
0
0%
|
Bilirubin |
0
0%
|
0
0%
|
0
0%
|
Calcium, Low |
0
0%
|
0
0%
|
0
0%
|
Calcium, High |
0
0%
|
0
0%
|
0
0%
|
Cholesterol |
0
0%
|
0
0%
|
0
0%
|
Creatine Kinase |
16
1.5%
|
10
2.1%
|
3
1%
|
Creatinine |
1
0.1%
|
0
0%
|
0
0%
|
Glomerular Filtration Rate, Estimated |
1
0.1%
|
0
0%
|
0
0%
|
Glucose, Low |
1
0.1%
|
1
0.2%
|
1
0.3%
|
Glucose, High |
10
1%
|
1
0.2%
|
0
0%
|
LDL-cholesterol |
31
3%
|
15
3.1%
|
2
0.7%
|
Lactate Dehydrogenase |
0
0%
|
0
0%
|
0
0%
|
Potassium, Low |
2
0.2%
|
0
0%
|
0
0%
|
Potassium, High |
3
0.3%
|
2
0.4%
|
0
0%
|
Sodium, Low |
1
0.1%
|
0
0%
|
0
0%
|
Sodium, High |
0
0%
|
0
0%
|
0
0%
|
Triglycerides |
1
0.1%
|
1
0.2%
|
3
1%
|
Uric Acid |
0
0%
|
0
0%
|
0
0%
|
Hemoglobin |
2
0.2%
|
1
0.2%
|
0
0%
|
Lymphocytes, Low |
0
0%
|
0
0%
|
0
0%
|
Lymphocytes, High |
0
0%
|
1
0.2%
|
0
0%
|
Neutrophils |
4
0.4%
|
0
0%
|
1
0.3%
|
Platelets |
0
0%
|
0
0%
|
0
0%
|
White Blood Cells |
0
0%
|
0
0%
|
0
0%
|
Urine Erythrocytes |
0
0%
|
0
0%
|
0
0%
|
Urine Glucose |
10
1%
|
2
0.4%
|
0
0%
|
Urine Protein |
0
0%
|
0
0%
|
0
0%
|
Title | Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period |
---|---|
Description | Elevations of on-treatment AST or ALT > 3 x ULN concurrent with total bilirubin > 2 x ULN were defined as elevations on the same collection date. |
Time Frame | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed on treated participants. |
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
---|---|---|---|
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. |
Measure Participants | 1033 | 481 | 286 |
Number (95% Confidence Interval) [Percentage of participants] |
0.1
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period |
---|---|
Description | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation patient administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Hepatic AEs were defined as all on-treatment PTs under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those PTs in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ. |
Time Frame | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed on treated participants. |
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
---|---|---|---|
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. |
Measure Participants | 1033 | 481 | 286 |
Hepatic-related AE |
16
1.5%
|
10
2.1%
|
0
0%
|
Hepatic-related AE leading to discontinuation |
3
0.3%
|
3
0.6%
|
0
0%
|
Adverse Events
Time Frame | Adverse events were reported from start of study drug treatment up to 52 weeks | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | The analysis was performed on treated participants. | |||||
Arm/Group Title | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | |||
Arm/Group Description | To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks. | To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While ontreatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks. | |||
All Cause Mortality |
||||||
PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1033 (0%) | 0/481 (0%) | 0/286 (0%) | |||
Serious Adverse Events |
||||||
PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 28/1033 (2.7%) | 16/481 (3.3%) | 3/286 (1%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Gastrointestinal disorders | ||||||
Appendiceal mucocoele | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Colitis ischaemic | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Constipation | 1/1033 (0.1%) | 1/481 (0.2%) | 0/286 (0%) | |||
Diabetic gastroparesis | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Gastritis | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Pancreatitis acute | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Peritoneal haemorrhage | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
General disorders | ||||||
Chest pain | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Pyrexia | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Hepatobiliary disorders | ||||||
Cholecystitis | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Cholecystitis chronic | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Infections and infestations | ||||||
Appendicitis | 0/1033 (0%) | 3/481 (0.6%) | 0/286 (0%) | |||
Bronchitis | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Cellulitis | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Gastroenteritis viral | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Influenza | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Mastitis | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Pneumonia | 2/1033 (0.2%) | 0/481 (0%) | 0/286 (0%) | |||
Sepsis | 1/1033 (0.1%) | 0/481 (0%) | 1/286 (0.3%) | |||
Viral sepsis | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Accidental overdose | 3/1033 (0.3%) | 0/481 (0%) | 0/286 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthritis | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Musculoskeletal chest pain | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Osteoarthritis | 2/1033 (0.2%) | 1/481 (0.2%) | 0/286 (0%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Colon cancer | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Invasive ductal breast carcinoma | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Uterine leiomyoma | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Nervous system disorders | ||||||
Headache | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Hemiplegia | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Hemiplegic migraine | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Migraine | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Migraine with aura | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Psychiatric disorders | ||||||
Suicidal ideation | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Renal and urinary disorders | ||||||
Nephrolithiasis | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Reproductive system and breast disorders | ||||||
Haemorrhagic ovarian cyst | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Menorrhagia | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Asthma | 0/1033 (0%) | 1/481 (0.2%) | 0/286 (0%) | |||
Pulmonary embolism | 1/1033 (0.1%) | 1/481 (0.2%) | 1/286 (0.3%) | |||
Skin and subcutaneous tissue disorders | ||||||
Lipodystrophy acquired | 0/1033 (0%) | 0/481 (0%) | 1/286 (0.3%) | |||
Vascular disorders | ||||||
Aortic dissection | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Deep vein thrombosis | 1/1033 (0.1%) | 0/481 (0%) | 0/286 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 224/1033 (21.7%) | 100/481 (20.8%) | 27/286 (9.4%) | |||
Infections and infestations | ||||||
Nasopharyngitis | 72/1033 (7%) | 41/481 (8.5%) | 9/286 (3.1%) | |||
Sinusitis | 57/1033 (5.5%) | 28/481 (5.8%) | 7/286 (2.4%) | |||
Upper respiratory tract infection | 108/1033 (10.5%) | 38/481 (7.9%) | 12/286 (4.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Biohaven Pharmaceuticals, Inc. |
Phone | 203-404-0410 |
clinicaltrials@biohavenpharma.com |
- BHV3000-201