Preventive Treatment of MigrainePhase 3NCT07729462
A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine
A Phase 3 study testing Rimegepant in people with Preventive Treatment of Migraine, run by Pfizer at 21 sites in 2 countries.
Trial summary
Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventive Treatment of Migraine
- What is being tested?
- Rimegepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 26 Aug 2026to 19 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Male or female participants ≥18 years of age.
- Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
- History of migraine for at least 1 year before screening.
- Migraine onset before 50 years of age and chronic migraine onset before 65 years of age.
- Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated.
- During the 3 months prior to screening, an average of:
Show all 11Show fewer
- ≥15 monthly headache days (MHDs),
- including ≥8 monthly migraine days (MMDs),
- and ≥1 non-headache day per month.
- Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization.
- Willing and able to comply with study procedures, including completion of the electronic diary.
Who cannot join
- Prior use of rimegepant for migraine prevention.
- History of treatment failure of:
- 2 gepants, or
- 2 CGRP-targeting biologics, or
- 1 gepant and ≥1 CGRP-targeting biologic.
- Failure of >4 migraine preventive medications, including at least 2 with different mechanisms of action.
Show all 11Show fewer
- Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon.
- Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study.
- Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation.
- Use of investigational products or participation in another clinical study within protocol-defined exclusion windows.
- Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
United States19 sites, 19 recruiting
- Recruiting
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
- Recruiting
Austin Clinical Trial Partners
Austin, Texas, 78737
- Recruiting
Neurology Offices of South Florida PLLC
Boca Raton, Florida, 33428
- Recruiting
Hope Clinical Research
Canoga Park, California, 91303
- Recruiting
StudyMetrix Research
City of Saint Peters, Missouri, 63303
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
- Recruiting
Neuro-Pain Research Center
Fresno, California, 93710
- Recruiting
Josephson Wallack Munshower Neurology,PC
Indianapolis, Indiana, 46256
- Recruiting
Clinical Research Institute
Los Angeles, California, 90048
- Recruiting
Clinical Neuroscience Solutions, LLC.
Memphis, Tennessee, 38119
- Recruiting
Hightower Clinical
Oklahoma City, Oklahoma, 73120
- Recruiting
Collective Medical Research
Overland Park, Kansas, 66212
- Recruiting
Papillion Research Center / Avacare
Papillion, Nebraska, 68046
- Not yet recruiting
Highland Clinical Research
Salt Lake City, Utah, 84124
- Recruiting
Clinical Endpoints
Scottsdale, Arizona, 85258
- Not yet recruiting
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
- Recruiting
Conquest Research-Winter Park
Winter Park, Florida, 32789
- Not yet recruiting
New England Regional Headache Center, Inc.
Worcester, Massachusetts, 01609
Israel2 sites, 2 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
- Recruiting
Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER
Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.
After a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study.
Read more
The primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability.
Approximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.
Read the detailed description
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of rimegepant 75 mg administered once daily for the preventive treatment of chronic migraine in adults. Approximately 400 participants with chronic migraine will complete a 28-day Observation Phase and then be randomized in a 1:1 ratio to receive either rimegepant 75 mg or placebo during a 12-week Double-Blind Treatment (DBT) Phase.
The primary objective is to determine whether once-daily rimegepant is superior to placebo in reducing monthly migraine days in adults with chronic migraine. Secondary objectives include evaluation of migraine responder rates, headache frequency and severity, acute migraine medication use, quality of life, headache-related disability, work productivity, cognitive functioning, and patient-reported improvement.
Participants will record migraine and headache information using an electronic diary and will complete protocol-specified efficacy and safety assessments throughout the study. Safety evaluations will include monitoring of adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and other protocol-defined safety measures.
Eligible participants who complete the DBT Phase and remain eligible may enter a 12-week Open-Label Extension (OLE) Phase, during which all participants will receive open-label rimegepant 75 mg once daily. During the OLE Phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. Following completion or discontinuation of study treatment, participants will enter a 28-day Follow-Up Phase.
The study is designed to determine whether once-daily rimegepant provides superior efficacy to placebo for the preventive treatment of chronic migraine in adults and to further characterize the safety and tolerability profile of daily rimegepant administration.
- Conditions
- Preventive Treatment of Migraine
- Being tested
- Rimegepant, Placebo
- Keywords
- Migraine Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Rimegepant 75 mg orally disintegrating tablet (ODT) administered once daily during the 12-week double-blind treatment phase. Participants who enter the 12-week open-label extension phase will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough headache attacks, up to 10 doses per month.
PlaceboDrug
Matching placebo orally disintegrating tablet administered once daily during the 12-week double-blind treatment phase. Participants who enter the 12-week open-label extension phase will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough headache attacks, up to 10 doses per month.
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant 75 mg orally disintegrating tablet (ODT) once daily | Experimental | Participants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. Receives: Drug: Rimegepant |
| Matching placebo once daily for 12 weeks during the double-blind treatment phase | Placebo comparator | Participants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
Change from the Observation Phase in the number of monthly migraine days (MMDs) over the 12-week Double-Blind Treatment Phase. Monthly migraine days will be assessed using participant-reported electronic diary data.
Measured: 12 Weeks
Secondary outcomes (7)
Percentage of Participants Achieving a ≥50% Reduction From the Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
A responder is defined as a participant who achieves a reduction of at least 50% from the Observation Phase in monthly migraine days (MMDs). Monthly migraine days will be determined using participant-reported electronic diary data.
Measured: 12 Weeks
Change From Observation Phase in Moderate or Severe Monthly Headache Days Over the Entire Double-Blind Treatment Phase
Change from the Observation Phase in the number of moderate or severe monthly headache days. Headache intensity will be recorded using participant-reported electronic diary data.
Measured: 12 Weeks
Change From Observation Phase in Monthly Acute Migraine Medication Use Days Over the Entire Double-Blind Treatment Phase
Change from the Observation Phase in the number of monthly acute migraine medication use days. Acute migraine medication use will be captured using participant-reported electronic diary data.
Measured: 12 Weeks
Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Restrictive Role Function Domain Score
The Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1 Restrictive Role Function domain assesses limitations in daily social and work-related activities due to migraine. Scores range from 0 to 100, with higher scores indicating better functioning and fewer migraine-related limitations.
Measured: Week 12
Change From Observation Phase in Monthly Migraine Days Over the Entire Double-Blind Treatment Phase in Participants With Historical Medication Overuse Headache and Medication Overuse
Change from the Observation Phase in the number of monthly migraine days among participants with both historical medication overuse headache and medication overuse during the Observation Phase. Monthly migraine days will be determined using participant-reported electronic diary data.
Measured: 12 Weeks
Change From Baseline in MSQ Restrictive Role Function Domain Score in Participants With Historical Medication Overuse Headache and Medication Overuse
The Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1 Restrictive Role Function domain assesses limitations in daily social and work-related activities due to migraine. Scores range from 0 to 100, with higher scores indicating better functioning and fewer migraine-related limitations. This analysis will be performed among participants with both historical medication overuse headache and medication overuse during the Observation Phase.
Measured: Week 12
Percentage of Participants Achieving Medication Overuse Headache Remission
Percentage of participants with both historical medication overuse headache and medication overuse during the Observation Phase who achieve medication overuse headache remission during the Double-Blind Treatment Phase.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start26 Aug 2026
- Primary completion21 Oct 2028 (estimated)
- Study completion19 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive Treatment of 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study in which participants are assigned 1:1 to rimegepant 75 mg once daily or placebo for 12 weeks, followed by a 12-week open-label extension in which all participants receive rimegepant.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
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
- NCT07729462
- Sponsor's protocol ID
- C4951085
- Other IDs
- 2026-525295-25-00
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER
- ClinicalTrials.gov ID
- NCT07729462
- Acronym / sponsor ID
- C4951085
- Conditions
- Preventive Treatment of Migraine
- Keywords
- Migraine Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 21 Oct 2028 (estimated)
- Study completion
- 19 Jan 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.
After a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study.
The primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability.
Approximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.
Detailed description
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of rimegepant 75 mg administered once daily for the preventive treatment of chronic migraine in adults. Approximately 400 participants with chronic migraine will complete a 28-day Observation Phase and then be randomized in a 1:1 ratio to receive either rimegepant 75 mg or placebo during a 12-week Double-Blind Treatment (DBT) Phase.
The primary objective is to determine whether once-daily rimegepant is superior to placebo in reducing monthly migraine days in adults with chronic migraine. Secondary objectives include evaluation of migraine responder rates, headache frequency and severity, acute migraine medication use, quality of life, headache-related disability, work productivity, cognitive functioning, and patient-reported improvement.
Participants will record migraine and headache information using an electronic diary and will complete protocol-specified efficacy and safety assessments throughout the study. Safety evaluations will include monitoring of adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and other protocol-defined safety measures.
Eligible participants who complete the DBT Phase and remain eligible may enter a 12-week Open-Label Extension (OLE) Phase, during which all participants will receive open-label rimegepant 75 mg once daily. During the OLE Phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. Following completion or discontinuation of study treatment, participants will enter a 28-day Follow-Up Phase.
The study is designed to determine whether once-daily rimegepant provides superior efficacy to placebo for the preventive treatment of chronic migraine in adults and to further characterize the safety and tolerability profile of daily rimegepant administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study in which participants are assigned 1:1 to rimegepant 75 mg once daily or placebo for 12 weeks, followed by a 12-week open-label extension in which all participants receive rimegepant.
| Arm | Type | Receives |
|---|---|---|
| Rimegepant 75 mg orally disintegrating tablet (ODT) once daily | Experimental | Drug: RimegepantParticipants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. |
| Matching placebo once daily for 12 weeks during the double-blind treatment phase | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female participants ≥18 years of age.
- Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
- History of migraine for at least 1 year before screening.
- Migraine onset before 50 years of age and chronic migraine onset before 65 years of age.
- Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated.
Key exclusion criteria (11 listed)
- Prior use of rimegepant for migraine prevention.
- History of treatment failure of:
- Failure of >4 migraine preventive medications, including at least 2 with different mechanisms of action.
- Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon.
- Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study.
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 |
|---|---|---|
| RimegepantRimegepant 75 mg orally disintegrating tablet (ODT) administered once daily during the 12-week double-blind treatment phase. Participants who enter the 12-week open-label extension phase will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough headache attacks, up to 10 doses per month. | Drug | Rimegepant 75 mg orally disintegrating tablet (ODT) once daily |
| PlaceboMatching placebo orally disintegrating tablet administered once daily during the 12-week double-blind treatment phase. Participants who enter the 12-week open-label extension phase will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough headache attacks, up to 10 doses per month. | Drug | Matching placebo once daily for 12 weeks during the double-blind treatment phase |
Primary outcome
Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
Time frame: 12 Weeks
Change from the Observation Phase in the number of monthly migraine days (MMDs) over the 12-week Double-Blind Treatment Phase. Monthly migraine days will be assessed using participant-reported electronic diary data.
7 secondary outcomes
Percentage of Participants Achieving a ≥50% Reduction From the Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
Time frame: 12 Weeks
Change From Observation Phase in Moderate or Severe Monthly Headache Days Over the Entire Double-Blind Treatment Phase
Time frame: 12 Weeks
Change From Observation Phase in Monthly Acute Migraine Medication Use Days Over the Entire Double-Blind Treatment Phase
Time frame: 12 Weeks
Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Restrictive Role Function Domain Score
Time frame: Week 12
Change From Observation Phase in Monthly Migraine Days Over the Entire Double-Blind Treatment Phase in Participants With Historical Medication Overuse Headache and Medication Overuse
Time frame: 12 Weeks
Change From Baseline in MSQ Restrictive Role Function Domain Score in Participants With Historical Medication Overuse Headache and Medication Overuse
Time frame: Week 12
Percentage of Participants Achieving Medication Overuse Headache Remission
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- 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.
Related trials for Preventive Treatment of Migraine
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
Not yet recruiting
EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
Migraine Disorders, Refractory Migraine
RecruitingPhase 4
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
Migraine
RecruitingPhase 3
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Chronic Migraine in Children
Active, not recruitingPhase 3
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
Migraine
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.
Pfizer CT.gov Call Center study director
Pfizer
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimegepant in people with Preventive Treatment of Migraine, run by Pfizer at 21 sites in 2 countries.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Israel. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.