Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Rimegepant 75 MG
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Medstar Health Research Institute
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov