[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608061":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":55,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregabalin group","ACTIVE_COMPARATOR",null,[13],"Drug: Pregabalin",{"label":15,"type":16,"description":11,"interventionNames":17},"Crisugabalin group","EXPERIMENTAL",[18],"Drug: Crisugabalin",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Pregabalin","For the pregabalin group, treatment will be initiated at a dosage of 150 mg daily, administered into 2 or 3 divided doses. After 3 to 7 days, the dose will be titrated to 300 mg per day, with subsequent incremental increases of 150 mg daily permitted at 3-day to 7-day intervals based on therapeutic response and tolerability, up to a maximum dose of 450 mg daily.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Crisugabalin","For the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Fang Luo, M.D.","CONTACT","+86 13611326978","13611326978@163.com",[36],{"facility":37,"status":38,"city":39,"state":11,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Beijing Tiantan Hospital, Beijing, Beijing 100070","RECRUITING","Beijing","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":51,"phoneExt":11,"email":34},"Fang Luo","+8613611326978",{"type":53,"investigatorFullName":50,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Director, Department of Pain Management, Principal Investigator, Clinical Professor",[56,58,60,62,64,66,68,70,72],{"name":57,"class":6},"China-Japan Friendship Hospital",{"name":59,"class":6},"The First Affiliated Hospital of Nanchang University",{"name":61,"class":6},"Peking University Third Hospital",{"name":63,"class":6},"The Fourth Affiliated Hospital of Harbin Medical University",{"name":65,"class":6},"Zhongnan Hospital",{"name":67,"class":6},"Xiangya Hospital of Central South University",{"name":69,"class":6},"The Affiliated Hospital of Yanbian University",{"name":71,"class":6},"The Second Hospital University of South China",{"name":73,"class":6},"LanZhou University","100608061","the-efficacy-and-safety-of-pregabalin-and-crisugabalin-in-patients-with-fibromyalgia-100608061",false,"NCT07196657","The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia","Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Crisugabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study","Inclusion Criteria:\n\n* Diagnosed with FM according to the 2016 Revisions to the 2010\u002F2011 FM diagnostic criteria;\n* Aged over 18 years old;\n* Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM;\n* Baseline numeric rating scale (NRS) score of 4 or higher;\n* Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;\n* Estimated glomerular filtration rate (eGFR) of at least 30 mL\u002Fmin\u002F1.73 m²;\n* Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements;\n\nExclusion Criteria:\n\n* Previous allergic reactions to pregabalin, crisugabalin, or any of their excipients;\n* Prior diagnosis of epilepsy or depression requiring antidepressant therapy;\n* Women who are pregnant or breastfeeding;\n* Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;\n* Suffering from acute or chronic pain disorders other than FM.","ALL","18 Years",{"count":84,"type":85},1116,"ESTIMATED","INTERVENTIONAL",[88],"NA","Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. crisugabalin, a new highly selective α2δ ligand, has shown potential in animal models or preliminary clinical trials, but there is insufficient evidence for its application in FM. This study aims to explore the effectiveness and safety of pregabalin or crisugabalin in treating FM, with the aim of providing a better treatment option for FM patients.",[91,22,92],"Fibromyalgia","Pain","2026-02-09",{"date":95,"type":96},"2026-02-11","ACTUAL",{"date":98,"type":96},"2025-09-30",{"date":100,"type":85},"2027-08-31",{"name":5,"class":6},1]