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NOT YET RECRUITING
NCT07518810
PHASE2/PHASE3

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-04-10

Completion Date

2027-10-10

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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). For 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.

Locations (6)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

HuZhou Central Hospital

Huzhou, Zhejiang, China

The Second Hospital of Jiaxing

Jiaxing, Zhejiang, China

Ningbo Second Hospital

Ningbo, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, China