Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy

A vizsgálat adatai

Ki végzi

Second Affiliated Hospital, Zhejiang University, School of Medicine

Azonosító

NCT07518810

A regiszteradat frissítve

2026. október 16.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy（ENMSA）: A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial

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:

1. To evaluate whether NBP soft capsules, compared with placebo, alleviates the major clinical symptoms in patients with MSA. 2. 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

Participants of ENMSA will:

1. Take NBP or Placebo three times a day for 6 months 2. Be served with clinical visit four times for follow-up and tests 3. Keep a diary of drug application and symptom changes

Bevonási feltételek: 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; 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; 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; 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/depression agents, and sleep aids.

Kizáró feltételek: 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; Patients with a history of other major neurological disorders, including ischemic stroke, intracranial hemorrhage, epilepsy, encephalitis, or central nervous system demyelinating diseases; Patients with a history of psychiatric disorders that may involve psychotic symptoms, such as schizophrenia, major depressive disorder, or dissociative -conversion disorders; Patients with a heamorrhage event within the past 3 months or a high bleeding risk; Patients with a history of significant craniocerebral trauma or surgery; Patients with severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24); Patients with a history of malignancy or autoimmune diseases; Patients with dysphagia due to severe medullary dysfunction or esophageal disorders, or those unable to comply with medication administration for other reasons; Patients with severe hepatic or renal impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >2 xULN; Estimated creatinine clearance <30 mL/min; Patients who are pregnant, lactating, or planning a pregnancy within the next year.

ClinicalTrials.gov NCT07518810