NCT07609914RecruitingPhase 4
A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine
A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack. The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 20 May 2026
- Start date
- 28 May 2026
- Primary completion date
- 7 Jun 2028
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT07609914
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 28 May 2026 to the primary completion date, 7 Jun 2028
- 24 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion:
- Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition
- Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) \<15 monthly headache days (MHDs) (migraine or non-migraine); and (3) \<7 monthly non-migraine headache days.
- Exclusion:
- Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Not yet recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Abington Neurological Associates Coordinator of this site? Confirm its status | Abington | United States | Not yet recruiting |
| Michigan Headache & Neurological Institute Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| FutureSearch Trials of Neurology Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Neurology Offices of South Florida Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| Minneapolis Clinic of Neurology - Burnsville Office Coordinator of this site? Confirm its status | Burnsville | United States | Recruiting |
| Hope Clinical Research Coordinator of this site? Confirm its status | Canoga Park | United States | Recruiting |
| Cedar Crosse Research Center Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| FutureSearch Trials of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Neuro Pain Research Center Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| Headache Wellness Center Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Josephson Wallack Munshower Neurology Coordinator of this site? Confirm its status | Indianapolis | United States | Not yet recruiting |
| Red Star Research, LLC Coordinator of this site? Confirm its status | Lake Jackson | United States | Recruiting |
| Alliance Clinical Research Las Vegas (Excel Clinical Research) Coordinator of this site? Confirm its status | Las Vegas | United States | Not yet recruiting |
| M3 Wake Research - Las Vegas Rainbow Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Clinical Research Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Medstar Health - Department of Neurology Coordinator of this site? Confirm its status | McLean | United States | Recruiting |
| Brainstorm Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| AppleMedical Research Group, Inc. Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Clinical Neuroscience Solutions Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Proven Endpoints, LLC Coordinator of this site? Confirm its status | Ridgeland | United States | Recruiting |
| New England Regional Headache Center Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.