Multiple System Atrophy - Parkinsonian Type (MSA-P)
Conditions
Interventions
Test group:Treatment with Idebenone Tablets
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 30 to 70 years; 2.Diagnosis of clinically established or clinically probable Multiple System Atrophy according to the Chinese Expert Consensus on Diagnostic Criteria for Multiple System Atrophy (2022), with predominant motor symptoms consistent with the MSA-P subtype; 3.Time from symptom onset to screening does not exceed 3 years; 4.Provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with other chronic neurodegenerative diseases of the nervous system, such as Alzheimer's disease, idiopathic Parkinson's disease, amyotrophic lateral sclerosis, etc; 2.Patients with other cerebellar impairment-related diseases such as spinocerebellar ataxia, cerebellitis, or those with a clinical subtype of pure MSA-C; 3.Patients with paraneoplastic syndrome or vascular parkinsonism; 4.Patients with conditions such as impaired consciousness, aphasia, or psychiatric disorders who are unable to cooperate with neuropsychological testing 5.Patients with severe comorbidities that may affect treatment efficacy, tolerability, or data interpretation; 6.Patients anticipated to use other medications during the study period that could interfere with the trial; 7.Patients with known hypersensitivity to the investigational drug or its excipients; 8.Pregnant or lactating women, or patients planning pregnancy; 9.Patients with an expected survival of less than 3 years; 10.Patients whom the investigator deems to have potential risks or any other factors that may interfere with the subject, making them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Multiple System Atrophy Rating Scale (UMSARS)-?+? score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions leading to treatment discontinuation;Incidence of Adverse Events;Unified Multiple System Atrophy Rating Scale (UMSARS)-?+?;The total score of the Unified Multiple System Atrophy Rating Scale (UMSARS);Post-void residual urine volume;Abnormal Laboratory Findings;Systolic blood pressure drop during orthostatic measurement (measured separately during "on" and "off" periods);Plasma GDF-15 levels;Activities of Daily Living (ADL) scale score;Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) score;Mini-Mental State Examination (MMSE);Hamilton Depression Rating Scale (HAMD) score;Fatigue Severity Scale (FSS) score;Montreal Cognitive Assessment (MoCA) score;Incidence of Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactYiming Liu
Qilu Hospital of Shandong University
Outcome results
None listed