[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654113":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":38,"interventions":51,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":83,"collaborators":26,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":26,"overallStatus":106,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"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\u002For 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.","Baseline to Weeks 9-12",{"measure":14,"description":15,"timeFrame":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\u002For 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.",[17,20,23],{"measure":18,"description":19,"timeFrame":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.",{"measure":21,"description":22,"timeFrame":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)",{"measure":24,"description":25,"timeFrame":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.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Rimegepant","EXPERIMENTAL","Participants randomized to this arm will receive Rimegepant 75 mg administered orally every other day for 12 weeks.",[44],"Drug: Rimegepant 75 MG",{"label":46,"type":47,"description":48,"interventionNames":49},"Placebo","PLACEBO_COMPARATOR","Participants randomized to this arm will receive matching placebo capsules administered orally every other day for 12 weeks.",[50],"Drug: Placebo",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":26},"DRUG","Rimegepant 75 MG","Rimegepant 75 mg oral capsule administered every other day for 12 weeks",[40],{"type":53,"name":46,"description":58,"armGroupLabels":59,"otherNames":26},"Matching placebo oral capsule administered every other day for 12 weeks.",[46],[61],{"name":62,"affiliation":5,"role":63},"Yohannes Woldeamanuel, MD","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},"Clinical Studies Unit","CONTACT","480-342-2906","Woldeamanuel.YohannesWoubishet@mayo.edu",[71],{"facility":5,"status":26,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":26},"Phoenix","Arizona","85054","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-112.07404,33.44838,{"lat":81,"lon":80},{"type":63,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Yohannes Woubishet Woldeamanuel","Principal Investigator","100654113","phase-2-rimegepant-for-endometriosis-pain-100654113",false,"NCT07795125","Rimegepant For Endometriosis Pain","A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain","Inclusion Criteria\n\n* Consent: Female subjects, aged 18 to 45 years inclusive, who are able to provide written informed consent.\n* Surgical Confirmation: Histologically confirmed diagnosis of endometriosis via surgical pathology performed within the 3 to 6 months prior to screening.\n* Pain Severity: Presence of moderate-to-severe endometriosis-associated pain, defined as an EDPI score of 2 or higher during the screening period.\n* Contraceptive Requirement: Current use of an effective method of contraception (including hormonal contraceptives, intra-uterine devices, or sterilization). Subjects must commit to continuing the same contraceptive method throughout the 12-week study to avoid confounding pain levels and ensure safety.\n* Pregnancy Testing: Willingness to undergo urine at in person visits and urine hCG at home pregnancy testing at screening and every 4 weeks (Weeks 0, 4, 8, and 12) during the trial.\n\nExclusion Criteria\n\n* Pregnancy and Lactation: Pregnant or breastfeeding women. Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.\n* Menopausal Status: Women who are menopausal, whether through natural onset or surgical intervention.\n* Cardiovascular and Metabolic Disease: History of cardiovascular disease, stroke, uncontrolled hypertension, or diabetes.\n* Organ Impairment: Presence of severe kidney or liver disease (specifically ALT\u002FAST \\>2x ULN).\n* Medication and Allergy: Known hypersensitivity or allergy to rimegepant or other CGRP-targeting medications.\n* Lack of Contraception: Women not currently using an effective method of contraception, including those not on medication or not sterilized.\n* Prior Clinical Trial Exposure: Participation in another investigational drug or device trial within 30 days prior to screening.\n* Compliance: Inability to comply with study procedures, including the daily electronic EDPI diary and mandatory in-person clinic visits.","FEMALE","18 Years","45 Years",{"count":97,"type":98},132,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","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.",[104,105],"Endometriosis","Endometriosis-related Pain","NOT_YET_RECRUITING","2026-08-26",{"date":109,"type":110},"2026-08-31","ACTUAL",{"date":112,"type":98},"2026-09-30",{"date":114,"type":98},"2031-09-30",{"name":5,"class":6},1]