Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy
In plain words A Phase 2 and 3 study of wild celery extract in people 30 to 80, run by Second Affiliated Hospital, Zhejiang University, School of Medicine. It plans to enroll about 150 people at 7 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 30 to 80. Conditions: Multiple System Atrophy.
- 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
The exclusion criteria are on the listing.
What it tests, as registered
3-N-butylphthalide
Registered 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. The full summary is on the listing.
Where, as registered
No US site; China (7).