Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy（ENMSA）: A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
NOT_YET_RECRUITING
Beijing
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
HuZhou Central Hospital
RECRUITING
Huzhou
The Second Hospital of Jiaxing
RECRUITING
Jiaxing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Ningbo Second Hospital
RECRUITING
Ningbo
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING
Taizhou
Contact Information
Primary
Jiali Pu, MD
jialipu@zju.edu.cn
+86 13989468062
Time Frame
Start Date:2026-08-27
Estimated Completion Date:2027-10-10
Participants
Target number of participants:150
Treatments
Experimental: NBP treatment group
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.
Placebo_comparator: Placebo control group
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.
Collaborators: Huzhou Central Hospital, Ningbo No.2 Hospital, Beijing Chao Yang Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Guangxi Medical University
Leads: Second Affiliated Hospital, Zhejiang University, School of Medicine