A Phase 4 interventional study of Rimegepant in Migraine, Episodic Migraine and Phonophobia, sponsored by Pfizer. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.
This is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 441 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
rimegepant 75 mg ODT daily
Drug: Rimegepant
rimegepant ODT 75mg daily
Also known as: BHV-3000
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With On-Treatment Serious Adverse Events (SAEs)
An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment.
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With AEs Leading to Study Drug Discontinuation
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure.
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening).
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening).
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
| Milestone | Rimegepant |
|---|---|
| Started | 250 |
| Completed | 187 |
| Not completed | 63 |
| Withdrew: Adverse event | 7 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Non-compliance | 3 |
| Withdrew: Other | 17 |
| Withdrew: Physician decision | 2 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Protocol-specified withdrawal criterion met | 14 |
| Withdrew: Withdrawal by subject | 10 |
| Milestone | Rimegepant |
|---|---|
| Started | 235 |
| Completed | 220 |
| Not completed | 15 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Non-compliance | 1 |
| Withdrew: Not reported | 2 |
| Withdrew: Not collected | 11 |
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
| Participants | Rimegepant |
|---|---|
| Mild | 33 |
| Moderate | 17 |
| Moderate or severe | 17 |
An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment.
| Participants | Rimegepant |
|---|---|
| Number of Participants With On-Treatment Serious Adverse Events (SAEs) | 0 |
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure.
| Participants | Rimegepant |
|---|---|
| Number of Participants With AEs Leading to Study Drug Discontinuation | 7 |
The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening).
| Participants | Rimegepant |
|---|---|
| Eosinophils | 0 |
| Hemoglobin, low | 0 |
| Hemoglobin, high | 0 |
| Leukocytes, low | 0 |
| Lymphocytes, low | 1 |
| Lymphocytes, high | 0 |
| Neutrophils | 0 |
| Platelets | 0 |
| Alanine Aminotransferase | 0 |
| Albumin | 0 |
| Alkaline Phosphatase | 0 |
| Aspartate Aminotransferase | 0 |
| Bicarbonate | 0 |
| Bilirubin | 0 |
| Calcium, low | 0 |
| Calcium, high | 0 |
| Cholesterol | 0 |
| Creatine Kinase | 9 |
| Creatinine | 0 |
| Glomerular Filtration Rate, Estimated | 0 |
| Glucose, low | 1 |
| Glucose, high | 0 |
| Lactate Dehydrogenase | 0 |
| LDL Cholesterol | 22 |
| LDL Cholesterol, fasting | 14 |
| LDL Cholesterol, not fasting | 9 |
| Potassium, low | 0 |
| Potassium, high | 3 |
| Sodium, low | 0 |
| Sodium, high | 0 |
| Triglycerides | 2 |
| Triglycerides, fasting | 2 |
| Triglycerides, not fasting | 0 |
| Uric Acid | 0 |
| Urine Glucose | 1 |
| Urine Protein | 0 |
The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening).
| Participants | Rimegepant |
|---|---|
| Eosinophils | 0 |
| Hemoglobin | 4 |
| Leukocytes, low | 0 |
| Leukocytes, high | 0 |
| Lymphocytes | 1 |
| Neutrophils | 0 |
| Platelets | 0 |
| Alanine Aminotransferase | 0 |
| Albumin | 0 |
| Alkaline Phosphatase | 0 |
| Aspartate Aminotransferase | 0 |
| Bilirubin | 1 |
| Blood Urine Nitrogen | 1 |
| Calcium, low | 0 |
| Calcium, high | 0 |
| Cholesterol | 54 |
| Creatinine | 0 |
| Glucose, low | 4 |
| Glucose, high | 19 |
| Potassium, low | 0 |
| Potassium, high | 10 |
| Protein | 1 |
| Sodium, low | 0 |
| Sodium, high | 6 |
| Urine Glucose | 1 |
| Urine Protein | 0 |
Collected over For On-treatment period: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks); For Follow-up period- from 2 weeks after last dose of study treatment up to 8 weeks after last dose of study treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rimegepant (On-treatment Period) | 0/250 (0%) | 0/250 (0%) | 48/250 (19.2%) |
| Rimegepant (Follow-up Period) | 0/235 (0%) | 2/235 (0.9%) | 2/235 (0.9%) |
| Event | Rimegepant (On-treatment Period) | Rimegepant (Follow-up Period) |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 0/250 | 1/235 |
| Suicide attemptPsychiatric disorders | 0/250 | 1/235 |
| Event | Rimegepant (On-treatment Period) | Rimegepant (Follow-up Period) |
|---|---|---|
| NasopharyngitisInfections and infestations | 23/250 | 1/235 |
| COVID-19Infections and infestations | 16/250 | 0/235 |
| NauseaGastrointestinal disorders | 15/250 | 1/235 |
| Age, Continuous(Years) | Rimegepant |
|---|---|
| Mean | 42.6 ± 14.05 |
| Sex: Female, Male(Participants) | Rimegepant |
|---|---|
| Female | 206 |
| Male | 44 |
| Ethnicity (NIH/OMB)(Participants) | Rimegepant |
|---|---|
| Hispanic or Latino | 35 |
| Not Hispanic or Latino | 215 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Rimegepant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 11 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 23 |
| White | 216 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimegepant