Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Recruiting · NCT07301008 · Interventional (participants receive a specific treatment) · Lead sponsor: Medstar Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Rimegepant 75 MG
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- MedStar Health: Neurology at McLean - McLean, Virginia, United States