Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 2/3
Started
2026-04-10
Last updated
2026-04-09
Condition(s) studied
Multiple System Atrophy
Investigational drug(s) / intervention(s)
3-N-butylphthalide
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.
Study 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
Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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;
2. 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;
3. 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;
4. 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
Exclusion Criteria:
1. Patients with a diagnosis confirmed by PET-CT or revised during follow-up to other diseases, such as idiopathic Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, dementia with Lewy bodies, or secondary parkinsonian syndromes.
2. Patients with a history of other major neurological disorders, including ischemic stroke, intracranial hemorrhage, epilepsy, encephalitis, or central nervous system demyelinating diseases;
3. Patients with a history of psychiatric disorders that may involve psychotic symptoms, such as schizophrenia, major depressive disorder, or dissociative -conversion disorders.
4. Patients with severe hepatic or renal impairment (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels \>2 xULN; Estimated creatinine clearance \<30 mL/min;
5. Patients with a heamorrhage event within the past 3 months or a high bleeding risk;
6. Patients with a history of significant craniocerebral trauma or surgery;
7. Patients with severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \<24);
8. Patients with a history of malignancy or autoimmune diseases;
9. Patients with dysphagia due to severe medullary dysfunction or esophageal disorders, or those unable to comply with medication administration for other reasons;
10. Patients who are pregnant, lactating, or planning a pregnancy within the next year.
Primary outcome measure(s)
Main symptom control of MSA — Baseline; 1st, 3rd, 6th, 12th month after intervention initiation Use sum score Movement Disorder Society-Unified Multiple System Atrophy Rating Scale(MDS-UMSARS; score range: 0-104; higher score means worse symptoms of MSA) part I+II to evaluate the effectiveness of main symptom control of MSA
Trial sites (6)
Facility
City
Region
Status
The First Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
HuZhou Central Hospital
Huzhou
Zhejiang
The Second Hospital of Jiaxing
Jiaxing
Zhejiang
Ningbo Second Hospital
Ningbo
Zhejiang
Taizhou Hospital of Zhejiang Province
Taizhou
Zhejiang
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing
China
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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