Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US (RIM)

MedStar Health

Status and phase

Enrolling

Phase 4

Conditions

Migraine

Trigger Induced Migraine

Treatments

Drug: Rimegepant 75 MG

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07301008

STUDY00008797

Details and patient eligibility

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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