MigraineNCT07906262
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
An observational study of Migraine, run by Pfizer at 1 site in United States.
Trial summary
This non-interventional study will evaluate the efficacy of rimegepant 75 mg compared with placebo for the acute treatment of moderate or severe migraine attacks using individual participant data (IPD) from six completed randomized, double-blind, placebo-controlled clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2026to 31 Dec 2026
- Phase
- Observational
- 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
Study population: The study population consists of adult participants with migraine with or without aura who were enrolled in six completed randomized, double-blind, placebo-controlled clinical trials evaluating rimegepant 75 mg for the acute treatment of migraine. Participants were recruited across multiple geographic regions, including the United States, Europe, China, South Korea, and Japan. Individual participant data from these completed trials will be pooled and analyzed to estimate treatment effects in predefined target populations and clinically relevant subgroups.
Who may be able to join
- Participants enrolled in one of six completed randomized, double-blind, placebo-controlled clinical trials of rimegepant 75 mg for the acute treatment of migraine.
- Adults diagnosed with migraine with or without aura according to the eligibility criteria of the parent clinical trial.
- Randomized to receive either rimegepant 75 mg or placebo for treatment of a qualifying moderate or severe migraine attack.
- Availability of participant-level data required for the planned analyses.
Who cannot join
- Participants with missing treatment assignment information.
- Participants lacking data necessary for evaluation of the relevant efficacy endpoints or prespecified covariates used in the analyses.
- Participants excluded from the parent clinical trials according to the original study-specific eligibility criteria.
Trial locations and contacts
1 site in 1 country.
About this study
This non-interventional study will evaluate the efficacy of rimegepant 75 mg compared with placebo for the acute treatment of moderate or severe migraine attacks using individual participant data (IPD) from six completed randomized, double-blind, placebo-controlled clinical trials. The analysis includes data from adult participants with migraine with or without aura enrolled across studies conducted in the United States, China, South Korea, Japan, and multiple European and other international locations.
Although the efficacy of rimegepant has been established in individual trials and previous pooled analyses, conventional meta-analyses provide average treatment effects based on the mix of participants enrolled in the included studies and may not reflect outcomes expected in specific patient populations. The primary objective is to estimate the average treatment effects of rimegepant 75 mg relative to placebo for moderate or severe migraine attacks with respect to pain and symptom relief in prespecified target populations, including regional populations from Europe, the United States, China, South Korea, and Japan. A secondary objective is to evaluate treatment effects within clinically relevant subgroups defined by demographic and clinical characteristics.
Because this study uses existing data from completed clinical trials, no new participant recruitment, treatment assignment, or data collection will be conducted. The findings will contribute to the evidence base for rimegepant in the acute treatment of migraine.
Read the detailed description
Migraine is a disabling neurological disorder characterized by recurrent attacks of moderate to severe headache that are commonly accompanied by symptoms such as nausea, photophobia, and phonophobia. Acute treatment aims to relieve symptoms during individual migraine attacks and restore normal functioning. Rimegepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine with or without aura in adults. Multiple randomized, double-blind, placebo-controlled clinical trials have demonstrated the efficacy of a single 75 mg dose of rimegepant across diverse patient populations and geographic regions. Previous pooled analyses and aggregate-data meta-analyses have shown that rimegepant provides clinically meaningful improvements in key acute migraine efficacy outcomes compared with placebo. However, conventional pooled analyses estimate treatment effects based on the combined populations enrolled in the contributing studies and are not standardized to any specific patient population. Because treatment response may vary according to demographic, geographic, and clinical characteristics, average effects derived from pooled study populations may not accurately reflect the benefits expected in specific populations of interest. This study is a non-interventional, Bayesian individual participant data (IPD) meta-analysis that will use participant-level data from six completed randomized, double-blind, placebo-controlled clinical trials evaluating rimegepant 75 mg for the acute treatment of migraine. The contributing studies were conducted in the United States, China, South Korea, Japan, and multiple European and other international locations. The primary objective is to estimate the average treatment effects of rimegepant 75 mg relative to placebo for moderate or severe migraine attacks. A secondary objective is to estimate treatment effects within clinically relevant patient subgroups. The primary efficacy endpoints are pain freedom at 2 hours postdose, freedom from the most bothersome symptom at 2 hours postdose, and pain relief at 2 hours postdose. Secondary endpoints include pain freedom and pain relief at earlier time points; return to normal functioning; sustained pain freedom and sustained pain relief through 24 and 48 hours after dosing; freedom from nausea, photophobia, and phonophobia; and use of rescue medication within 24 hours after dosing. By integrating participant-level data from multiple clinical trials and applying modern standardization methods, this study aims to provide robust and clinically relevant estimates of the efficacy of rimegepant 75 mg across defined geographic populations and patient subgroups. The findings are expected to support evidence-based interpretation of rimegepant efficacy for the acute treatment of migraine.
- Conditions
- Migraine
- Being tested
- Rimegepant, Placebo
- Keywords
- Migraine, Acute Migraine, Migraine With Aura;, Migraine WithoutAura,, Rimegepant;, CGRP Receptor Antagonist, IndividualParticipant Data Meta-analysis
- Medical subject headings
- Migraine Disorders, Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
75mg
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant 75 mg | Participants from the included randomized, double-blind, placebo-controlled clinical trials who were randomized to receive rimegepant 75 mg for the acute treatment of a moderate or severe migraine attack. Receives: Drug: Rimegepant | |
| Placebo | Participants from the included randomized, double-blind, placebo-controlled clinical trials who were randomized to receive placebo for the acute treatment of a moderate or severe migraine attack. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Freedom at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who achieve pain freedom 2 hours after treatment of a moderate or severe migraine attack.
Measured: 2 hours after administration of study treatment
Freedom From the Most Bothersome Symptom at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who are free from their prespecified most bothersome migraine-associated symptom 2 hours after treatment.
Measured: 2 hours after administration of study treatment
Pain Relief at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants achieving pain relief 2 hours after treatment of a moderate or severe migraine attack.
Measured: 2 hours after administration of study treatment
Secondary outcomes (15)
Pain Freedom at 1 Hour Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who achieve pain freedom 1 hour after treatment of a moderate or severe migraine attack.
Measured: 1 hour after administration of study treatment
Pain Relief at 1 Hour Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants achieving pain relief 1 hour after treatment of a moderate or severe migraine attack.
Measured: 1 hour after administration of study treatment
Return to Normal Function at 1 Hour Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants with normal function 1 hour after treatment.
Measured: 1 hour after administration of study treatment
Return to Normal Function at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants with normal function 2 hours after treatment.
Measured: 2 hours after administration of study treatment
Sustained Pain Freedom From 2 to 24 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants with sustained pain freedom from 2 through 24 hours after treatment.
Measured: 2 to 24 hours after administration of study treatment
Sustained Pain Freedom From 2 to 48 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants with sustained pain freedom from 2 through 48 hours after treatment.
Measured: 2 to 48 hours after administration of study treatment
Sustained Pain Relief From 2 to 24 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants with sustained pain relief from 2 through 24 hours after treatment.
Measured: 2 to 24 hours after administration of study treatment
Sustained Pain Relief From 2 to 48 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants with sustained pain relief from 2 through 48 hours after treatment.
Measured: 2 to 48 hours after administration of study treatment
Freedom From Nausea at 1 Hour Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants free from nausea 1 hour after treatment among participants with nausea present at dosing.
Measured: 1 hour after administration of study treatment
Freedom From Nausea at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants free from nausea 2 hours after treatment among participants with nausea present at dosing.
Measured: 2 hours after administration of study treatment
Freedom From Photophobia at 1 Hour Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants free from photophobia 1 hour after treatment among participants with photophobia present at dosing.
Measured: 1 hour after administration of study treatment
Freedom From Photophobia at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants free from photophobia 2 hours after treatment among participants with photophobia present at dosing.
Measured: 2 hours after administration of study treatment
Freedom From Phonophobia at 1 Hour Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants free from phonophobia 1 hour after treatment among participants with phonophobia present at dosing.
Measured: 1 hour after administration of study treatment
Freedom From Phonophobia at 2 Hours Postdose
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants free from phonophobia 2 hours after treatment among participants with phonophobia present at dosing.
Measured: 2 hours after administration of study treatment
Rescue Medication Use Within 24 Hours Postdose
Rescue medication use within 24 hours post dose is a binary outcome indicating whether an evaluable participant used rescue medication after administration of study treatment and within 24 hours post dose. The treatment effect of rimegepant 75 mg relative to placebo will be summarized using the risk difference (RD) as the primary effect measure and the risk ratio (RR) as the secondary effect measure.
Measured: Within 24 hours after administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start12 Oct 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 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
- NCT07906262
- Sponsor's protocol ID
- C4951099
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
- ClinicalTrials.gov ID
- NCT07906262
- Acronym / sponsor ID
- C4951099
- Conditions
- Migraine
- Keywords
- Migraine, Acute Migraine, Migraine With Aura;, Migraine WithoutAura,, Rimegepant;, CGRP Receptor Antagonist, IndividualParticipant Data Meta-analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 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.
This non-interventional study will evaluate the efficacy of rimegepant 75 mg compared with placebo for the acute treatment of moderate or severe migraine attacks using individual participant data (IPD) from six completed randomized, double-blind, placebo-controlled clinical trials. The analysis includes data from adult participants with migraine with or without aura enrolled across studies conducted in the United States, China, South Korea, Japan, and multiple European and other international locations.
Although the efficacy of rimegepant has been established in individual trials and previous pooled analyses, conventional meta-analyses provide average treatment effects based on the mix of participants enrolled in the included studies and may not reflect outcomes expected in specific patient populations. The primary objective is to estimate the average treatment effects of rimegepant 75 mg relative to placebo for moderate or severe migraine attacks with respect to pain and symptom relief in prespecified target populations, including regional populations from Europe, the United States, China, South Korea, and Japan. A secondary objective is to evaluate treatment effects within clinically relevant subgroups defined by demographic and clinical characteristics.
Because this study uses existing data from completed clinical trials, no new participant recruitment, treatment assignment, or data collection will be conducted. The findings will contribute to the evidence base for rimegepant in the acute treatment of migraine.
Detailed description
Migraine is a disabling neurological disorder characterized by recurrent attacks of moderate to severe headache that are commonly accompanied by symptoms such as nausea, photophobia, and phonophobia. Acute treatment aims to relieve symptoms during individual migraine attacks and restore normal functioning. Rimegepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine with or without aura in adults. Multiple randomized, double-blind, placebo-controlled clinical trials have demonstrated the efficacy of a single 75 mg dose of rimegepant across diverse patient populations and geographic regions. Previous pooled analyses and aggregate-data meta-analyses have shown that rimegepant provides clinically meaningful improvements in key acute migraine efficacy outcomes compared with placebo. However, conventional pooled analyses estimate treatment effects based on the combined populations enrolled in the contributing studies and are not standardized to any specific patient population. Because treatment response may vary according to demographic, geographic, and clinical characteristics, average effects derived from pooled study populations may not accurately reflect the benefits expected in specific populations of interest. This study is a non-interventional, Bayesian individual participant data (IPD) meta-analysis that will use participant-level data from six completed randomized, double-blind, placebo-controlled clinical trials evaluating rimegepant 75 mg for the acute treatment of migraine. The contributing studies were conducted in the United States, China, South Korea, Japan, and multiple European and other international locations. The primary objective is to estimate the average treatment effects of rimegepant 75 mg relative to placebo for moderate or severe migraine attacks. A secondary objective is to estimate treatment effects within clinically relevant patient subgroups. The primary efficacy endpoints are pain freedom at 2 hours postdose, freedom from the most bothersome symptom at 2 hours postdose, and pain relief at 2 hours postdose. Secondary endpoints include pain freedom and pain relief at earlier time points; return to normal functioning; sustained pain freedom and sustained pain relief through 24 and 48 hours after dosing; freedom from nausea, photophobia, and phonophobia; and use of rescue medication within 24 hours after dosing. By integrating participant-level data from multiple clinical trials and applying modern standardization methods, this study aims to provide robust and clinically relevant estimates of the efficacy of rimegepant 75 mg across defined geographic populations and patient subgroups. The findings are expected to support evidence-based interpretation of rimegepant efficacy for the acute treatment of migraine.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimegepant 75 mg | – | Drug: RimegepantParticipants from the included randomized, double-blind, placebo-controlled clinical trials who were randomized to receive rimegepant 75 mg for the acute treatment of a moderate or severe migraine attack. |
| Placebo | – | Drug: PlaceboParticipants from the included randomized, double-blind, placebo-controlled clinical trials who were randomized to receive placebo for the acute treatment of a moderate or severe migraine attack. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult participants with migraine with or without aura who were enrolled in six completed randomized, double-blind, placebo-controlled clinical trials evaluating rimegepant 75 mg for the acute treatment of migraine. Participants were recruited across multiple geographic regions, including the United States, Europe, China, South Korea, and Japan. Individual participant data from these completed trials will be pooled and analyzed to estimate treatment effects in predefined target populations and clinically relevant subgroups.
Key inclusion criteria (4 listed)
- Participants enrolled in one of six completed randomized, double-blind, placebo-controlled clinical trials of rimegepant 75 mg for the acute treatment of migraine.
- Adults diagnosed with migraine with or without aura according to the eligibility criteria of the parent clinical trial.
- Randomized to receive either rimegepant 75 mg or placebo for treatment of a qualifying moderate or severe migraine attack.
- Availability of participant-level data required for the planned analyses.
Key exclusion criteria (3 listed)
- Participants with missing treatment assignment information.
- Participants lacking data necessary for evaluation of the relevant efficacy endpoints or prespecified covariates used in the analyses.
- Participants excluded from the parent clinical trials according to the original study-specific eligibility criteria.
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 |
|---|---|---|
| Rimegepant75mg | Drug | Rimegepant 75 mg |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Pain Freedom at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who achieve pain freedom 2 hours after treatment of a moderate or severe migraine attack.
Freedom From the Most Bothersome Symptom at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who are free from their prespecified most bothersome migraine-associated symptom 2 hours after treatment.
Pain Relief at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants achieving pain relief 2 hours after treatment of a moderate or severe migraine attack.
15 secondary outcomes
Pain Freedom at 1 Hour Postdose
Time frame: 1 hour after administration of study treatment
Pain Relief at 1 Hour Postdose
Time frame: 1 hour after administration of study treatment
Return to Normal Function at 1 Hour Postdose
Time frame: 1 hour after administration of study treatment
Return to Normal Function at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Sustained Pain Freedom From 2 to 24 Hours Postdose
Time frame: 2 to 24 hours after administration of study treatment
Sustained Pain Freedom From 2 to 48 Hours Postdose
Time frame: 2 to 48 hours after administration of study treatment
Sustained Pain Relief From 2 to 24 Hours Postdose
Time frame: 2 to 24 hours after administration of study treatment
Sustained Pain Relief From 2 to 48 Hours Postdose
Time frame: 2 to 48 hours after administration of study treatment
Freedom From Nausea at 1 Hour Postdose
Time frame: 1 hour after administration of study treatment
Freedom From Nausea at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Freedom From Photophobia at 1 Hour Postdose
Time frame: 1 hour after administration of study treatment
Freedom From Photophobia at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Freedom From Phonophobia at 1 Hour Postdose
Time frame: 1 hour after administration of study treatment
Freedom From Phonophobia at 2 Hours Postdose
Time frame: 2 hours after administration of study treatment
Rescue Medication Use Within 24 Hours Postdose
Time frame: Within 24 hours after administration of study treatment
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 30 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Pfizer at 1 site 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 30 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 1 site 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.
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?
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?
Pain Freedom at 2 Hours Postdose (time frame: 2 hours after administration of study treatment). The study lists 3 primary outcomes in all. 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 30 Oct 2026.