NCT07301008 Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
| NCT ID | NCT07301008 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medstar Health Research Institute |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-09-09 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute 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 evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes. * Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder. * Women must not be pregnant, lactating or breastfeeding
Contact & Investigator
Jessica Ailani, MD
PRINCIPAL INVESTIGATOR
MedStar's Georgetown University Hospital
Frequently Asked Questions
Who can join the NCT07301008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07301008 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07301008 currently recruiting?
Yes, NCT07301008 is actively recruiting participants. Contact the research team at yemisrach.g.tadesse@medstar.net for enrollment information.
Where is the NCT07301008 trial being conducted?
This trial is being conducted at McLean, United States.
Who is sponsoring the NCT07301008 clinical trial?
NCT07301008 is sponsored by Medstar Health Research Institute. The principal investigator is Jessica Ailani, MD at MedStar's Georgetown University Hospital. The trial plans to enroll 60 participants.
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