The motor symptoms, autonomic dysfunction and cerebellar ataxia of multiple system atrophy
Conditions
Interventions
Butylphthalide group:Orally taken Butylphthalide capsule
Placebo group:Placebo
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
Male
Age
30 Years to 80 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autonomic function;Main symptom control of MSA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall symptom control of MSA;Mood function;Life quality of MSA;Safety of Butylphthalide capsule;Cognitive function; | — |
Countries
China
Contacts
Public ContactJiali Pu
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed