NCT07518810尚未招募2 期
Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy（ENMSA）: A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Main symptom control of MSA
研究概览
简要总结
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:
- To evaluate whether NBP soft capsules, compared with placebo, alleviates the major clinical symptoms in patients with MSA.
- 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:
- Take NBP or Placebo three times a day for 6 months
- Be served with clinical visit four times for follow-up and tests
- Keep a diary of drug application and symptom changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 severe hepatic or renal impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >2 xULN; Estimated creatinine clearance <30 mL/min;
- •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 who are pregnant, lactating, or planning a pregnancy within the next year.
研究组 & 干预措施
NBP treatment group
Experimental
Participants in the NBP treatment group will receive NBP soft capsules (dosage form: 100 mg/capsule), 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.
干预措施: 3-N-butylphthalide (Drug)
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.
干预措施: 3-N-butylphthalide (Drug)
结局指标
主要结局
Main symptom control of MSA
时间窗: Baseline; 1st, 3rd, 6th, 12th month after intervention initiation
Use sum score Movement Disorder Society-Unified Multiple System Atrophy Rating Scale(MDS-UMSARS; score range: 0-104; higher score means worse symptoms of MSA) part I+II to evaluate the effectiveness of main symptom control of MSA
次要结局
- Overall symptom control of MSA(Baseline; 1st, 3rd, 6th, 12th month after intervention initiation)
- Autonomic function of MSA(Baseline; 6th, 12th month after intervention initiation)
- Depressive symptom of MSA(Baseline; 6th, 12th month after intervention initiation)
- Cognitive function of MSA(Baseline; 6th, 12th month after intervention initiation)
- Life quality of MSA(Baseline; 6th, 12th month after intervention initiation)
- Safety of Butylphthalide application in MSA patients(through study completion, an average of 1 year)
- Anxiety symptoms of MSA(Baseline; 6th, 12th month after intervention initiation)
- Advanced Cognitive function of MSA(Baseline; 6th, 12th month after intervention initiation)
研究者
研究点 (6)
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