ClinicalTrials.gov record NCT07518810

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy（ENMSA）: A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2/3A study that tests whether a treatment works while continuing to check safety, in a larger group than a phase 2 study alone. It combines the aims of phase 2 and phase 3 in one protocol.
Age30 years old to 80 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double‑blind, placebo‑controlled trial compares 3‑n‑butylphthalide (NBP) soft capsules with matched placebo in people with clinically established Multiple System Atrophy (MSA). Participants take two capsules three times daily for six months and keep a medication diary; assessments occur at scheduled visits and up to 12 months. The study measures symptom scores and monitors safety.

What it is studying. The study tests whether 3‑n‑butylphthalide (NBP), taken three times daily for six months, changes MSA clinical symptom scores (measured by the Movement Disorder Society‑Unified Multiple System Atrophy Rating Scale, MDS‑UMSARS) compared with placebo, and whether NBP is safe to use in this group.

What the researchers hope to learn. To evaluate whether NBP improves main and overall MSA symptoms (using MDS‑UMSARS), and to measure effects on autonomic symptoms, mood (depression and anxiety), cognition, quality of life, and the incidence of adverse events and MSA‑specific mortality.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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:

  • To evaluate whether NBP soft capsules, compared with placebo, alleviates the major clinical symptoms in patients with MSA.
  • 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:

  • Take NBP or Placebo three times a day for 6 months
  • Be served with clinical visit four times for follow-up and tests
  • Keep a diary of drug application and symptom changes

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • 3-N-butylphthalide

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Patients with a history of other major neurological disorders, including ischemic stroke, intracranial hemorrhage, epilepsy, encephalitis, or central nervous system demyelinating diseases;
  • Patients with a history of psychiatric disorders that may involve psychotic symptoms, such as schizophrenia, major depressive disorder, or dissociative -conversion disorders.
  • Patients with severe hepatic or renal impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >2 xULN; Estimated creatinine clearance <30 mL/min;
  • Patients with a heamorrhage event within the past 3 months or a high bleeding risk;
  • Patients with a history of significant craniocerebral trauma or surgery;
  • Patients with severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24);
  • Patients with a history of malignancy or autoimmune diseases;
  • Patients with dysphagia due to severe medullary dysfunction or esophageal disorders, or those unable to comply with medication administration for other reasons;
  • Patients who are pregnant, lactating, or planning a pregnancy within the next year.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take study capsules (2 capsules per dose) three times daily for six months—either 3‑N‑butylphthalide (NBP) or matching placebo—while keeping their usual medications unchanged. They will attend scheduled clinic visits for follow-up tests and symptom rating scales and will keep a daily diary of medication use and symptom changes. Required assessments include MRI and PET‑CT scans and repeated symptom questionnaires; the study team will monitor for adverse events and safety during the study. Some evaluations occur at baseline and at follow-up visits during and after the six‑month treatment period.

How the study is structured. A randomized, parallel‑group drug trial with quadruple masking (participants, care providers, investigators, and outcomes assessors blinded). Participants are assigned to either NBP soft capsules (100 mg per capsule; two capsules per dose, three times daily) or matching placebo for six months while keeping their usual medications unchanged. Clinical assessments and rating scales occur at baseline and scheduled follow‑up visits (including 1, 3, 6 and 12 months); safety is monitored through the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 10, 2026 (estimated)
Primary completion
Apr 10, 2027 (estimated)
Study completion
Oct 10, 2027 (estimated)
Target enrollment
150 participants (estimated)
Last updated on registry
Apr 9, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
  • The Second Affiliated Hospital of Jiaxing University
  • Beijing Chao Yang Hospital
  • Huzhou Central Hospital
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • First Affiliated Hospital of Guangxi Medical University
  • Ningbo No.2 Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi · China

    • Yousheng Xiao, MD
  • HuZhou Central Hospital

    Huzhou, Zhejiang · China

    • Ying Tan, MD
  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang · China

    • Yanping Wang, MD
  • Ningbo Second Hospital

    Ningbo, Zhejiang · China

    • Weinv Fan, MD
  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang · China

    • Suzhi Liu, MD
  • Affiliated Beijing Chaoyang Hospital of Capital Medical University

    Beijing · China

    • Chaodong Wang, MD

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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