MigrainePhase 4NCT05207865
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
A Phase 4 study testing Rimegepant in people with Migraine and Episodic Migraine, run by Pfizer at 19 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Episodic Migraine, Phonophobia
- What is being tested?
- Rimegepant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 19 sitesUnited States
- Study dates
- 15 Mar 2022to 2 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 -72 hours if untreated
- Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
- Subjects ≥ 18 years
Who cannot join
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit.
- Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.
- The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study
- History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit
- WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test at screening or prior to study drug administration
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
The Headache Clinic
Alexandria, Louisiana, 71301
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Boston Clinical Trials
Boston, Massachusetts, 02131
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Velocity Clinical Research
Cincinnati, Ohio, 45242
CVS HealthHub - East Brunswick
East Brunswick, New Jersey, 08816
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250
CVS HealthHub - Lawrenceville
Lawrenceville, New Jersey, 08648
Phoenix Medical Research, LLC
Miami, Florida, 33165
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
CVS HealthHUB - Runnemede
Runnemede, New Jersey, 08078
VIP Trails
San Antonio, Texas, 78230
VIP Trials
San Antonio, Texas, 78230
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
About this study
Official title: A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
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.
Read the detailed description
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.
- Conditions
- Migraine, Episodic Migraine, Phonophobia, Photophobia
- Being tested
- Rimegepant
- Medical subject headings
- Migraine Disorders, Hyperacusis, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Also called BHV-3000
rimegepant ODT 75mg daily
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant | Experimental | rimegepant 75 mg ODT daily Receives: Drug: Rimegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start15 Mar 2022
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207865
- Sponsor's protocol ID
- BHV3000-405
- Other IDs
- C4951011
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2022
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Antinew J, Fountaine RJ, Loprinzo V, Straghan E, Dubrovin S, DeBesi P, Vatakis N, Fullerton T. A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention. J Headache Pain. 2025 Dec 9;27(1):17. doi: 10.1186/s10194-025-02225-7.
PubMed 41366286
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
- ClinicalTrials.gov ID
- NCT05207865
- Acronym / sponsor ID
- BHV3000-405
- Conditions
- Migraine, Episodic Migraine, Phonophobia, Photophobia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rimegepant | Experimental | Drug: Rimegepantrimegepant 75 mg ODT daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 -72 hours if untreated
- Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
- Subjects ≥ 18 years
Key exclusion criteria (7 listed)
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit.
- Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.
- The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study
- History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit
- WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantAlso: BHV-3000rimegepant ODT 75mg daily | Drug | Rimegepant |
Primary outcome
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
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.
Number of Participants With On-Treatment Serious Adverse Events (SAEs)
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
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.
Number of Participants With AEs Leading to Study Drug Discontinuation
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
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.
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
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
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).
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41366286Antinew J, Fountaine RJ, Loprinzo V, Straghan E, Dubrovin S, DeBesi P, Vatakis N, Fullerton T. A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention. J Headache Pain. 2025 Dec 9;27(1):17. doi: 10.1186/s10194-025-02225-7.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rimegepant in people with Migraine and Episodic Migraine, run by Pfizer at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity (time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.