Open Label Safety Study in Acute Treatment of Migraine | NCT03266588

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Rimegepant	Experimental		Drug: Rimegepant

Name	Type	Description	Arm Group Labels	Other Names
Rimegepant	Drug	75 mg oral tablet	Rimegepant	BHV-3000

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period	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.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period	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.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	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.	PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Central Research Associates, Inc		Birmingham	Alabama	35205	United States
Coastal Clinical Research, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40629887	Derived	Ailani J, Pavlovic J, Pixton GC, Fullerton T. Rimegepant safety and patient-reported outcomes among triptan-naive, triptan-using, and triptan-failure participants: Subgroup analysis of an open-label, multicenter study. Cephalalgia. 2025 Jul;45(7):3331024251343309. doi: 10.1177/03331024251343309. Epub 2025 Jul 9.
39520634	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PRN (2-8) Group	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 22, 2018	Jun 15, 2020

Arm/Group Information

ID	Title	Description
BG000	PRN (2-8) Group	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.
BG001	PRN (9-14) Group	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.
BG002	Scheduled EOD + PRN Group	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00044.0± 11.79 BG00142.4± 12.41 BG00241.1± 12.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000917 BG001444 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00099 BG00154 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0004 BG0014 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0001033 BG001481 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period

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.

The analysis was performed on treated participants.

Posted

Count of Participants

Participants

PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

ID	Title	Description
OG000	PRN (2-8) Group	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.
OG001	PRN (9-14) Group	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.
OG002	Scheduled EOD + PRN Group	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.

Units	Counts
Participants	OG0001033 OG001481 OG002286

Title

Denominators

Categories

Overall number of participants with at least 1 AE

Title	Measurements
	OG000664 OG001315 OG002109

AE ≥5%-Upper respiratory tract infection

Primary

Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period

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.

The analysis was performed on treated participants.

Posted

Count of Participants

Participants

PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks

ID	Title	Description
OG000	PRN (2-8) Group	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.
OG001	PRN (9-14) Group

Secondary

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

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.

The analysis was performed on treated participants.

Posted

Number

95% Confidence Interval

Percentage of participants

PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

ID	Title	Description
OG000	PRN (2-8) Group	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.
OG001	PRN (9-14) Group	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.

Secondary

Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period

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.

The analysis was performed on treated participants.

Posted

Count of Participants

Participants

PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

ID	Title	Description
OG000	PRN (2-8) Group	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.
OG001	PRN (9-14) Group	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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PRN (2-8) Group	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.	1,033	28	1,033	224	1,033
EG001	PRN (9-14) Group	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.	481	16	481	100	481
EG002	Scheduled EOD + PRN Group	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.	286	3	286	27	286

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Appendiceal mucocoele	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Colitis ischaemic	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Constipation	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Diabetic gastroparesis	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Gastritis	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Pancreatitis acute	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Chest pain	General disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Pyrexia	General disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Cholecystitis	Hepatobiliary disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Cholecystitis chronic	Hepatobiliary disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Appendicitis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0013 affected481 at risk EG0020 affected286 at risk
Bronchitis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Cellulitis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Gastroenteritis viral	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Influenza	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Mastitis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Pneumonia	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0002 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Sepsis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0021 affected286 at risk
Viral sepsis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Accidental overdose	Injury, poisoning and procedural complications	meddra (21.1)	Systematic Assessment	EG0003 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Arthritis	Musculoskeletal and connective tissue disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	meddra (21.1)	Systematic Assessment	EG0002 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Headache	Nervous system disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Hemiplegia	Nervous system disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Hemiplegic migraine	Nervous system disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Migraine	Nervous system disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Migraine with aura	Nervous system disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Suicidal ideation	Psychiatric disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Nephrolithiasis	Renal and urinary disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Menorrhagia	Reproductive system and breast disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0011 affected481 at risk EG0020 affected286 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0011 affected481 at risk EG0021 affected286 at risk
Lipodystrophy acquired	Skin and subcutaneous tissue disorders	meddra (21.1)	Systematic Assessment	EG0000 affected1,033 at risk EG0010 affected481 at risk EG0021 affected286 at risk
Aortic dissection	Vascular disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk
Deep vein thrombosis	Vascular disorders	meddra (21.1)	Systematic Assessment	EG0001 affected1,033 at risk EG0010 affected481 at risk EG0020 affected286 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG00072 affected1,033 at risk EG00141 affected481 at risk EG0029 affected286 at risk
Sinusitis	Infections and infestations	meddra (21.1)	Systematic Assessment	EG00057 affected1,033 at risk EG00128 affected481 at risk EG0027 affected286 at risk
Upper respiratory tract infection	Infections and infestations	meddra (21.1)	Systematic Assessment	EG000108 affected1,033 at risk EG00138 affected481 at risk EG00212 affected286 at risk

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases