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Multiple System AtrophyPhase 2/3ENMSANCT07518810

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

A Phase 2/3 study testing 3-N-butylphthalide in people with Multiple System Atrophy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Multiple System Atrophy
What is being tested?
3-N-butylphthalide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
7 sitesChina
Study dates
27 Aug 2026to 10 Oct 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiali Pu, MD contact

+86 13989468062

jialipu@zju.edu.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Affiliated Beijing Chaoyang Hospital of Capital Medical University

    Beijing

    Chaodong Wang, MD

    Not yet recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jiali Pu, MD, +86 13989468062, jialipu@zju.edu.cn

    Recruiting

  • HuZhou Central Hospital

    Huzhou, Zhejiang

    Ying Tan, MD

    Recruiting

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang

    Yanping Wang, MD

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Yousheng Xiao, MD

    Not yet recruiting

  • Ningbo Second Hospital

    Ningbo, Zhejiang

    Weinv Fan, MD

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Suzhi Liu, MD

    Not yet recruiting

Other trials in China

About this study

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

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
Read more

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
Being tested
3-N-butylphthalide
Keywords
multiple system atrophy, 3-n-butylphthalide
Medical subject headings
Multiple System Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-N-butylphthalideDrug

    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 groups in NCT07518810
Study groupRoleWhat they receive
NBP treatment groupExperimentalParticipants in the NBP treatment group will receive NBP soft capsules (dosage form: 100 mg/capsule), two capsules per dose, three times daily (total daily dose of 600 mg). The whole treatment duration is six months, during which all patients will maintain their original medication unchanged.
Receives: Drug: 3-N-butylphthalide
Placebo control groupPlacebo comparatorParticipants in the Placebo control group will receive two Placebo soft capsules each time, three times daily (total daily dose of 600 mg). The whole application duration is six months, during which all patients will maintain their original medication unchanged.
Receives: Drug: 3-N-butylphthalide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Main symptom control of MSA

    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

    Measured: Baseline; 1st, 3rd, 6th, 12th month after intervention initiation

Secondary outcomes (8)

  1. Overall symptom control of MSA

    Use sub score of Movement Disorder Society-Unified Multiple System Atrophy Rating Scale(MDS-UMSARS; score range: 0-104; higher score means worse symptoms of MSA) to evaluate the overall effectiveness of main symptom control of MSA

    Measured: Baseline; 1st, 3rd, 6th, 12th month after intervention initiation

  2. Autonomic function of MSA

    Use Composite Autonomic Symptom Score 31 (COMPASS-31; score range: 0-100; higher score means worse autonomic symptoms of MSA) scale to evaluate autonomic symptoms of MSA

    Measured: Baseline; 6th, 12th month after intervention initiation

  3. Depressive symptom of MSA

    Use Hamilton Depression Scale (HAMD; score range: 0-52; higher score means worse depressive symptoms of MSA) scale to evaluate depressive symptom of MSA

    Measured: Baseline; 6th, 12th month after intervention initiation

  4. Cognitive function of MSA

    Use Mini-mental State Examination scale (MMSE; score range: 0-30; higher score means better cognitive function of MSA patients) to evaluate cognitive symptoms of MSA

    Measured: Baseline; 6th, 12th month after intervention initiation

  5. Life quality of MSA

    Use Multiple System Atrophy-Quality of Life (MSA-QoL; score range: 0-160; higher score means worse life quality of MSA) scale to evaluate life quality of MSA patients

    Measured: Baseline; 6th, 12th month after intervention initiation

  6. Safety of Butylphthalide application in MSA patients

    Monitoring the incidence of AE/SAE and MSA specific mortality rate during the trial

    Measured: through study completion, an average of 1 year

  7. Anxiety symptoms of MSA

    Use Hamilton Anxiety scale (HAMA; score range: 0-56; higher score means worse anxiety symptoms of MSA) to evaluate anxiety symptoms of MSA

    Measured: Baseline; 6th, 12th month after intervention initiation

  8. Advanced Cognitive function of MSA

    Use Montreal Cognitive Assessment (MoCA; score range: 0-30; higher score means better cognitive function of MSA) to evaluate cognitive symptoms of MSA

    Measured: Baseline; 6th, 12th month after intervention initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start27 Aug 2026
  3. Primary completion10 Apr 2027 (estimated)
  4. Study completion10 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to NBP group or Placebo group in parallel for the duration of the study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518810
Sponsor's protocol ID
2025-1012
Acronym
ENMSA
Status last verified
Oct 2025
First submitted
26 Mar 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Share IPD within 1 year after trail completion by public study protocol, CRF,Email Contact, etc.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 3-N-butylphthalide in people with Multiple System Atrophy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiali Pu, MD (+86 13989468062, jialipu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main symptom control of MSA (time frame: Baseline; 1st, 3rd, 6th, 12th month after intervention initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07518810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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