The purpose of this study is to evaluate the efficacy of rimegepant 75 mg versus placebo in reducing endometriosis-associated pain (EAP) in women with moderate-to-severe pain and histologically confirmed endometriosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Rimegepant 75 mg oral capsule administered every other day for 12 weeks
Matching placebo oral capsule administered every other day for 12 weeks.
Mayo Clinic
Phoenix, Arizona, United States
Change in Non-Menstrual Pelvic Pain (NMPP)
Non-menstrual pelvic pain will be assessed using the Endometriosis Daily Pain Impact (EDPI) score. The EDPI is a participant-reported numeric rating scale used to assess endometriosis-associated pain, with scores ranging from 0 to 10; higher scores indicate greater pain intensity and/or impact. The baseline value will be calculated from the pre-treatment baseline assessment period, and the post-baseline value will be calculated as the mean daily score during Weeks 9 through 12.
Time frame: Baseline to Weeks 9-12
Change in Dysmenorrhea (Menstrual Pain)
Dysmenorrhea (Menstrual Pain) will be assessed using the Endometriosis Daily Pain Impact (EDPI) score for dysmenorrhea. The EDPI (dysmenorrhea) is a participant-reported numeric rating scale that measures the severity of painful uterine cramping and pelvic pain specifically associated with the menstrual cycle. Scores range from 0 to 10; higher scores indicate greater pain intensity and/or impact. The baseline value will be calculated from the pre-treatment baseline assessment period, and the post-baseline value will be calculated as the mean daily score during Weeks 9 through 12.
Time frame: Baseline to Weeks 9-12
Proportion of Responders
The percentage of participants achieving clinically meaningful pain reduction, defined as a ≥40% reduction in the mean daily EDPI score for non-menstrual pelvic pain (NMPP) and a ≥60% reduction in the mean daily EDPI score for dysmenorrhea.
Time frame: Baseline to Weeks 9-12
Reduction in Rescue Analgesic Use
The change in the mean frequency (days per week) of rescue analgesic administration, reported as morphine milligram equivalents (MME)
Time frame: Baseline to Weeks 9-12
Reduction in Monthly Migraine Frequency
In the pre-specified subgroup of participants with comorbid migraine, the change from baseline in the number of monthly migraine days (MMD) as recorded in a daily headache diary.
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Time frame: Baseline to Weeks 9-12