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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
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.
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 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
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
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