An observational study in Migraine, sponsored by Pfizer. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Pfizer · Observational
Among 47 studies in Migraine Disorders by Pfizer — 10 open to participants now, 14 under way, 6 of them phase 3. Migraine Disorders · Pfizer.
Among the 47 studies in Migraine Disorders by Pfizer, this one is one of 5 that started in 2026, is one of 9 observational ones, reaches primary completion later than 2 of the 13 other live ones, and was the 47th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 1 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →10 of the 47 studies in Migraine Disorders by Pfizer are open now, in 12 countries. Each count lists the studies.
Of the 216 Migraine Disorders studies recruiting now, 65 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →47 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2026.
Median enrollment 723 across the 37 interventional studies, 528 across the 9 observational. Of the 30 that completed or were terminated, 24 (80%) have results posted.
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.
3 of the studies in Migraine Disorders by Pfizer that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06641466Phase 3PfizerA Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | 2026-11-29 |
| NCT07906262PfizerEfficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations | 2026-12-31 |
| NCT06995729PfizerA Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine | 2027-08-12 |
Among the 47 studies in Migraine Disorders by Pfizer, from their registry updates:
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Rimegepant
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.
Drug: Placebo
75mg
matching placebo
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 hours after administration of study treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 hours after administration of study treatment
Plan to share: 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.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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