[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632832":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":108,"collaborators":110,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":25,"studyType":137,"phases":138,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":147,"whyStopped":25,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NBP treatment group","EXPERIMENTAL","Participants in the NBP treatment group will receive NBP soft capsules (dosage form: 100 mg\u002Fcapsule), two capsules per dose, three times daily (total daily dose of 600 mg). The whole treatment duration is six months, during which all patients will maintain their original medication unchanged.",[13],"Drug: 3-N-butylphthalide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo control group","PLACEBO_COMPARATOR","Participants in the Placebo control group will receive two Placebo soft capsules each time, three times daily (total daily dose of 600 mg). The whole application duration is six months, during which all patients will maintain their original medication unchanged.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","3-N-butylphthalide","3-n-Butylphthalide (NBP), also known as celery seed oil extract, is a lipid-soluble compound isolated from celery seeds. NBP was approved by the China Food and Drug Administration (CFDA) in 2002 for the treatment of acute ischemic stroke. NBP has demonstrated significant improvement in motor deficits and exhibited neuroprotective effects in animal models of various neurodegenerative diseases, such as Alzheimer's disease (AD), Parkinson's disease (PD), and amyotrophic lateral sclerosis (ALS).\n\nFor NBP used in ENMSA trial, its dosage form is soft capsule, containing 100mg NBP per capsule. Application frequency will be three times a day, 2 capsules each time.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Jiali Pu, MD","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+86 13989468062","jialipu@zju.edu.cn",[37,52,64,75,86,97],{"facility":38,"status":25,"city":39,"state":40,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","China","CN",{"type":44,"coordinates":45},"Point",[46,47],108.31667,22.81667,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":25,"phoneExt":25,"email":25},"Yousheng Xiao, MD",{"facility":53,"status":25,"city":54,"state":55,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"HuZhou Central Hospital","Huzhou","Zhejiang",{"type":44,"coordinates":57},[58,59],120.0933,30.8703,{"lat":59,"lon":58},[62],{"name":63,"role":33,"phone":25,"phoneExt":25,"email":25},"Ying Tan, MD",{"facility":65,"status":25,"city":66,"state":55,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"The Second Hospital of Jiaxing","Jiaxing",{"type":44,"coordinates":68},[69,70],120.75,30.7522,{"lat":70,"lon":69},[73],{"name":74,"role":33,"phone":25,"phoneExt":25,"email":25},"Yanping Wang, MD",{"facility":76,"status":25,"city":77,"state":55,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Ningbo Second Hospital","Ningbo",{"type":44,"coordinates":79},[80,81],121.54945,29.87819,{"lat":81,"lon":80},[84],{"name":85,"role":33,"phone":25,"phoneExt":25,"email":25},"Weinv Fan, MD",{"facility":87,"status":25,"city":88,"state":55,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Taizhou Hospital of Zhejiang Province","Taizhou",{"type":44,"coordinates":90},[91,92],121.43312,28.66266,{"lat":92,"lon":91},[95],{"name":96,"role":33,"phone":25,"phoneExt":25,"email":25},"Suzhi Liu, MD",{"facility":98,"status":25,"city":99,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Affiliated Beijing Chaoyang Hospital of Capital Medical University","Beijing",{"type":44,"coordinates":101},[102,103],116.39723,39.9075,{"lat":103,"lon":102},[106],{"name":107,"role":33,"phone":25,"phoneExt":25,"email":25},"Chaodong Wang, MD",{"type":109,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[111,113,115,117,119,121],{"name":112,"class":6},"The Second Affiliated Hospital of Jiaxing University",{"name":114,"class":6},"Beijing Chao Yang Hospital",{"name":116,"class":6},"Huzhou Central Hospital",{"name":118,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":120,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":122,"class":6},"Ningbo No.2 Hospital","100632832","phase-2-efficacy-and-safety-of-butylphthalide-in-the-treatment-of-multiple-system-atrophy-100632832",false,"NCT07518810","Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy","Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy（ENMSA）: A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial","ENMSA","Inclusion Criteria:\n\n1. Meet a diagnosis for \"clinically established MSA\" according to the Movement Disorder Society (MDS) diagnostic criteria for multiple system atrophy revised in 2022, as assessed by a neurologist;\n2. Patients aged between 30 and 80 years, within 5 years since the initial diagnosis of MSA, and with a life expectancy greater than 3 years;\n3. Patients are not entirely dependent on a wheelchair or bedridden and are capable of cooperating with necessary assessments and examinations, including scale evaluations, magnetic resonance imaging (MRI), and PET-CT scans;\n4. Patients must have been on a stable medication regimen (for a duration of at least one month) prior to the trial, which may include drugs for anti-Parkinson, anti-autonomic dysfunction, anti-anxiety\u002Fdepression agents, and sleep aids\n\nExclusion Criteria:\n\n1. Patients with a diagnosis confirmed by PET-CT or revised during follow-up to other diseases, such as idiopathic Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, dementia with Lewy bodies, or secondary parkinsonian syndromes.\n2. Patients with a history of other major neurological disorders, including ischemic stroke, intracranial hemorrhage, epilepsy, encephalitis, or central nervous system demyelinating diseases;\n3. Patients with a history of psychiatric disorders that may involve psychotic symptoms, such as schizophrenia, major depressive disorder, or dissociative -conversion disorders.\n4. Patients with severe hepatic or renal impairment (alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\] levels \\>2 xULN; Estimated creatinine clearance \\\u003C30 mL\u002Fmin;\n5. Patients with a heamorrhage event within the past 3 months or a high bleeding risk;\n6. Patients with a history of significant craniocerebral trauma or surgery;\n7. Patients with severe cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score \\\u003C24);\n8. Patients with a history of malignancy or autoimmune diseases;\n9. Patients with dysphagia due to severe medullary dysfunction or esophageal disorders, or those unable to comply with medication administration for other reasons;\n10. Patients who are pregnant, lactating, or planning a pregnancy within the next year.","ALL","30 Years","80 Years",{"count":135,"type":136},150,"ESTIMATED","INTERVENTIONAL",[139,140],"PHASE2","PHASE3","The present study aims to conduct a randomized controlled trial to evaluate the efficacy and safety of 3-n-Butylphthalide (NBP) in improving symptoms in patients with Multiple System Atrophy (MSA). The main questions it aims to answer are:\n\n1. To evaluate whether NBP soft capsules, compared with placebo, alleviates the major clinical symptoms in patients with MSA.\n2. Whether NBP application is safe to treat patients with MSA. In this trial, NBP will be compared with placebo (similar soft capsule without effective component of NBP) to demonstrate if NBP can alleviates MSA symptoms\n\nParticipants of ENMSA will:\n\n1. Take NBP or Placebo three times a day for 6 months\n2. Be served with clinical visit four times for follow-up and tests\n3. Keep a diary of drug application and symptom changes",[143],"Multiple System Atrophy",[145,146],"multiple system atrophy","3-n-butylphthalide","NOT_YET_RECRUITING","2026-04-02",{"date":150,"type":151},"2026-04-09","ACTUAL",{"date":153,"type":136},"2026-04-10",{"date":155,"type":136},"2027-10-10",{"name":5,"class":6},6]