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

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.