RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine • ClinicalTrials.gov ID: NCT07518810

Registry updated: 2026-10-16

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Description

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

Interventions

3-N-butylphthalide (Drug)
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.

Eligibility criteria

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.

Conditions

Multiple System Atrophy

Locations

The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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