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drugset / Trial / NCT07518810

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

NCT07518810 ↗

Phase 2/3 Not yet recruiting 150 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University Beijing Chao Yang Hospital · collabFirst Affiliated Hospital of Guangxi Medical University · collabHuzhou Central Hospital · collabNingbo No.2 Hospital · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe Second Affiliated Hospital of Jiaxing University · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2026-04-10
Primary completion
2027-04-10
Completion
2027-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Butylphthalide Small molecule 200 mg —

Indications

multiple system atrophy