A Phase 2/3 interventional study of 3-N-butylphthalide in Multiple System Atrophy, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 7 sites in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2/3, Interventional, and Treatment
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:
Participants of ENMSA will:
207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.
This study's planned enrollment of 150 is above the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.
Browse Multiple System Atrophy studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Drug: 3-N-butylphthalide
Participants 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.
Drug: 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.
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
Time frame: Baseline; 1st, 3rd, 6th, 12th month after intervention initiation
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
Time frame: Baseline; 1st, 3rd, 6th, 12th month after intervention initiation
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
Time frame: Baseline; 6th, 12th month after intervention initiation
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
Time frame: Baseline; 6th, 12th month after intervention initiation
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
Time frame: Baseline; 6th, 12th month after intervention initiation
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
Time frame: Baseline; 6th, 12th month after intervention initiation
Safety of Butylphthalide application in MSA patients
Monitoring the incidence of AE/SAE and MSA specific mortality rate during the trial
Time frame: through study completion, an average of 1 year
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
Time frame: Baseline; 6th, 12th month after intervention initiation
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
Time frame: Baseline; 6th, 12th month after intervention initiation
α-Syn aggregates
Use blood sample collected from participents to evalute the α-Syn aggregates in blood
Time frame: Baseline; 6th month after intervention initiation
Plasma Neuro-filament light chain
Use plasma sample collected from participents to evalute the NfL concentration in MSA patients
Time frame: Baseline; 6th month after intervention initiation
Plan to share: Yes — Share IPD within 1 year after trail completion by public study protocol, CRF,Email Contact, etc.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 1 year after trial completion
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Apr 2027, 7 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → Aug 2026, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Butylphthalide
Second Affiliated Hospital, Zhejiang University, School of Medicine