A Phase 2/3 interventional study of Rimegepant in Migraine, With or Without Aura, sponsored by Pfizer. Completed at 98 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Pfizer · Phase 2/3, Interventional, and Treatment
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Among 32 studies testing rimegepant in Migraine Disorders — 13 open to participants now, 15 under way, 6 of them phase 3. rimegepant · Migraine Disorders.
Among the 32 studies testing rimegepant in Migraine Disorders, this one has the largest enrollment, is one of 3 that started in 2017, is one of 2 in phase 2/3, and was the 5th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →13 of the 32 studies testing rimegepant in Migraine Disorders are open now, in 12 countries. Recruiting first, the newest first:
University of South Florida · Sites in United States
Ages 18+ · Healthy volunteers
Pfizer · Sites in United States, Israel
Ages 18+
Pfizer · Sites in India
Ages 18+
Pfizer · Sites in United States, Israel
Ages 18+
Medstar Health Research Institute · Sites in United States
Ages 18+
By country, each count listing its studies:
rimegepant: first FDA approval 2020 (NURTEC ODT), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 16 · Phase 4 9
First in 2011; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,019 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 618 across the 32 interventional studies. Of the 17 that completed or were terminated, 15 (88%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 32 have an industry lead sponsor. The 8 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
47 studies in Migraine Disorders by Pfizer: 10 open now, 14 under way, 6 of them phase 3. Of 30 finished, 24 (80%) have results posted.
Among the 47 studies in Migraine Disorders by Pfizer, this one has the largest enrollment of the 37 interventional ones that give a count, is one of 3 that started in 2017, is one of 5 in phase 2/3, and was the 9th registered.
Pfizer’s Migraine Disorders studies by the year they started, since 2007.
3 of the studies testing rimegepant in Migraine Disorders that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06641466Phase 3PfizerA Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | 2026-11-29 |
| NCT07918053Chinese PLA General HospitalA Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals | 2027-06 |
| NCT07667621University of South FloridaA Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department | 2027-07 |
Add all 3 to your calendar (.ics) → With an account.
Among the 32 studies testing rimegepant in Migraine Disorders, from their registry updates:
Among Pfizer’s 47 in Migraine Disorders:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Rimegepant
75 mg oral tablet
Also known as: BHV-3000
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.
Time frame: 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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks
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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
The study was conducted at 103 centers in the United States.
| Milestone | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| Started | 1605 | 786 | 476 |
| Completed | 1089 | 511 | 308 |
| Not completed | 516 | 275 | 168 |
| Withdrew: Screen failure: eligibility criteria | 439 | 228 | 140 |
| Withdrew: Withdrawal by subject | 44 | 22 | 13 |
| Withdrew: Non-compliance | 18 | 12 | 10 |
| Withdrew: Lost to follow-up | 8 | 12 | 4 |
| Withdrew: Eligibility failure- baseline lab values | 3 | 1 | 0 |
| Withdrew: Protocol deviation | 1 | 0 | 0 |
| Withdrew: Other reasons | 3 | 0 | 1 |
| Milestone | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| Started | 1089 | 511 | 308 |
| Treated | 1033 | 481 | 286 |
| Completed | 683 | 271 | 243 |
| Not completed | 406 | 240 | 65 |
| Withdrew: Adverse event | 33 | 17 | 8 |
| Withdrew: Lack of efficacy | 41 | 31 | 5 |
| Withdrew: Lost to follow-up | 39 | 37 | 8 |
| Withdrew: Non-compliance | 126 | 57 | 7 |
| Withdrew: Pregnancy | 11 | 5 | 0 |
| Withdrew: Protocol deviation | 17 | 10 | 4 |
| Withdrew: Screen failure: eligibility criteria | 33 | 17 | 17 |
| Withdrew: Withdrawal by subject | 100 | 63 | 16 |
| Withdrew: No migraine treated by week 8 visit | 1 | 2 | 0 |
| Withdrew: Other reasons | 5 | 0 | 0 |
| Withdrew: Positive sheehan-sts score > 0 | 0 | 1 | 0 |
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.
| Participants | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| Overall number of participants with at least 1 AE | 664 | 315 | 109 |
| AE ≥5%-Upper respiratory tract infection | 108 | 38 | 12 |
| Mild-Upper respiratory tract infection | 56 | 21 | 8 |
| Moderate-Upper respiratory tract infection | 51 | 17 | 4 |
| Severe-Upper respiratory tract infection | 1 | 0 | 0 |
| AE ≥5%-Nasopharyngitis | 72 | 41 | 9 |
| Mild-Nasopharyngitis | 53 | 28 | 7 |
| Moderate-Nasopharyngitis | 19 | 13 | 2 |
| AE ≥5%-Sinusitis | 57 | 28 | 7 |
| Mild-Sinusitis | 26 | 19 | 5 |
| Moderate-Sinusitis | 30 | 9 | 2 |
| Severe-Sinusitis | 1 | 0 | 0 |
| SAEs | 28 | 16 | 3 |
| AEs leading to discontinuation | 24 | 16 | 8 |
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.
| Participants | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| Alanine Aminotransferase (ALT) | 3 | 2 | 0 |
| Aspartate Aminotransferase (AST) | 4 | 2 | 0 |
| Albumin | 0 | 0 | 0 |
| Alkaline Phosphatase | 0 | 0 | 0 |
| Bicarbonate | 0 | 0 | 0 |
| Bilirubin | 0 | 0 | 0 |
| Calcium, Low | 0 | 0 | 0 |
| Calcium, High | 0 | 0 | 0 |
| Cholesterol | 0 | 0 | 0 |
| Creatine Kinase | 16 | 10 | 3 |
| Creatinine | 1 | 0 | 0 |
| Glomerular Filtration Rate, Estimated | 1 | 0 | 0 |
| Glucose, Low | 1 | 1 | 1 |
| Glucose, High | 10 | 1 | 0 |
| LDL-cholesterol | 31 | 15 | 2 |
| Lactate Dehydrogenase | 0 | 0 | 0 |
| Potassium, Low | 2 | 0 | 0 |
| Potassium, High | 3 | 2 | 0 |
| Sodium, Low | 1 | 0 | 0 |
| Sodium, High | 0 | 0 | 0 |
| Triglycerides | 1 | 1 | 3 |
| Uric Acid | 0 | 0 | 0 |
| Hemoglobin | 2 | 1 | 0 |
| Lymphocytes, Low | 0 | 0 | 0 |
| Lymphocytes, High | 0 | 1 | 0 |
| Neutrophils | 4 | 0 | 1 |
| Platelets | 0 | 0 | 0 |
| White Blood Cells | 0 | 0 | 0 |
| Urine Erythrocytes | 0 | 0 | 0 |
| Urine Glucose | 10 | 2 | 0 |
| Urine Protein | 0 | 0 | 0 |
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.
| Percentage of participants | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| 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 | 0.1 (0.00 to 0.60) | 0 (0.00 to 0.96) | 0 (0.00 to 1.60) |
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.
| Participants | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| Hepatic-related AE | 16 | 10 | 0 |
| Hepatic-related AE leading to discontinuation | 3 | 3 | 0 |
Collected over Adverse events were reported from start of study drug treatment up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRN (2-8) Group | 0/1,033 (0%) | 28/1,033 (2.7%) | 224/1,033 (21.7%) |
| PRN (9-14) Group | 0/481 (0%) | 16/481 (3.3%) | 100/481 (20.8%) |
| Scheduled EOD + PRN Group | 0/286 (0%) | 3/286 (1%) | 27/286 (9.4%) |
| Event | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| AppendicitisInfections and infestations | 0/1033 | 3/481 | 0/286 |
| SepsisInfections and infestations | 1/1033 | 0/481 | 1/286 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/1033 | 1/481 | 1/286 |
| Lipodystrophy acquiredSkin and subcutaneous tissue disorders | 0/1033 | 0/481 | 1/286 |
| Accidental overdoseInjury, poisoning and procedural complications | 3/1033 | 0/481 | 0/286 |
| Appendiceal mucocoeleGastrointestinal disorders | 0/1033 | 1/481 | 0/286 |
| Colitis ischaemicGastrointestinal disorders | 0/1033 | 1/481 | 0/286 |
| ConstipationGastrointestinal disorders | 1/1033 | 1/481 | 0/286 |
| GastritisGastrointestinal disorders | 0/1033 | 1/481 | 0/286 |
| Peritoneal haemorrhageGastrointestinal disorders | 0/1033 | 1/481 | 0/286 |
| Event | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 108/1033 | 38/481 | 12/286 |
| NasopharyngitisInfections and infestations | 72/1033 | 41/481 | 9/286 |
| SinusitisInfections and infestations | 57/1033 | 28/481 | 7/286 |
The analysis was performed on treated participants.
| Age, Continuous(years) | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | Total |
|---|---|---|---|---|
| Mean | 44.0 ± 11.79 | 42.4 ± 12.41 | 41.1 ± 12.69 | 43.1 ± 12.15 |
| Sex: Female, Male(Participants) | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | Total |
|---|---|---|---|---|
| Female | 917 | 444 | 248 | 1609 |
| Male | 116 | 37 | 38 | 191 |
| Ethnicity (NIH/OMB)(Participants) | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 99 | 54 | 24 | 177 |
| Not Hispanic or Latino | 934 | 427 | 262 | 1623 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 4 | 2 | 10 |
| Asian | 16 | 7 | 9 | 32 |
| Native Hawaiian or Other Pacific Islander | 0 | 3 | 2 | 5 |
| Black or African American | 149 | 66 | 35 | 250 |
| White | 847 | 394 | 234 | 1475 |
| More than one race | 17 | 7 | 4 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | PRN (2-8) Group | PRN (9-14) Group | Scheduled EOD + PRN Group | Total |
|---|---|---|---|---|
| United States | 1033 | 481 | 286 | 1800 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Jul 2019, 22 months.
Results were first posted in Jul 2020, 11 months after primary completion.
Of 12 phase 2/3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimegepant