Butylphthalide for Multiple System Atrophy: tests safety and symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled trial evaluates the efficacy and safety of 3-n-butylphthalide (NBP) soft capsules in adults with clinically established MSA. Participants will take NBP or placebo three times daily for six months, with four clinical visits for assessments and tests, plus diary tracking of symptoms and adherence. The study compares NBP to an inert capsule to determine if NBP provides symptom relief and has an acceptable safety profile. Eligible participants are adults aged 30–80 within five years of MSA diagnosis, not wheelchair-bound, and on a stable medication regimen. Exclusion criteria include non-MSA diagnoses confirmed by imaging or follow-up revisions.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• HuZhou Central Hospital
  Huzhou, Zhejiang, China Recruiting
• The Second Hospital of Jiaxing
  Jiaxing, Zhejiang, China Recruiting
• Ningbo Second Hospital
  Ningbo, Zhejiang, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Not yet recruiting
• Taizhou Hospital of Zhejiang Province
  Taizhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Jiali Pu, MD — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Jiali Pu, MD
• Email: jialipu@zju.edu.cn
• Phone: +86 13989468062

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.