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

Study acronym: ENMSA
StatusRecruiting
PhasePhase 2/3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Apr 10, 2026 to Aug 27, 2026
    • Study sites: 6 to 7
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 8 entries
  2. Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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
Trial Details
NCT Number NCT07518810
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators: The Second Affiliated Hospital of Jiaxing University, Beijing Chao Yang Hospital, Huzhou Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, First Affiliated Hospital of Guangxi Medical University, Ningbo No.2 Hospital
Conditions
(from sponsor)		 Multiple System Atrophy
Related terms Multiple System Atrophy
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov