NCT07301008RecruitingPhase 4
Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Oct 2025
- Start date
- 9 Sept 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Medstar Health Research Institute
- Diseases
- Migraine
- NCT number
- NCT07301008
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 9 Sept 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- 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.
Prior treatment
- History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
Other illness
- Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.
Other
- Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment
- Women must not be pregnant, lactating or breastfeeding
Who the study is looking for
- Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)
- Men and women ≥ 18 years old .
- Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
- Headache/migraine onset before age 50 years
- Migraine attacks, on average, lasting 4-72 hours if untreated
- At least 48 hours between migraine attacks
- Ability to distinguish migraine attacks from tension or cluster headaches
- Particpants on SOC treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the course of the study
- Participant may have been on treatment with Botox or mAbs for the last 6 months
- Participants experience migraine ≥75% of the time following exposure to a trigger during the run-in period. Acceptable triggers include exercise, alcohol ( less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or weekend/ let-down
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MedStar Health: Neurology at McLean Coordinator of this site? Confirm its status | McLean | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.