Multiple System Atrophy (MSA) Multiple System Atrophy
Conditions
Interventions
Administration of MSA 01 or placebo for 52 weeks.
Sponsors
Mitsui Jun
Tsuji Shoji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the Time of Informed Consent 1. Patients diagnosed as 'clinically established' or 'clinically probable' MSA based on the revised MSA diagnostic criteria of the Movement Disorder Society (MDS). 2. Patients who are able to walk independently or with the use of assistive devices. 3. Patients who are able to attend outpatient visits at the participating study site. At the Start of Study Drug Administration 4. Patients who are able to discontinue the use of CoQ10 supplements.
Exclusion criteria
Exclusion criteria: 1. Patients with severe neurological disorders, other progressive movement disorders, or cognitive impairment. 2. Patients with severe liver disease. 3. Patients with a known history of hypersensitivity to any component of the investigational drug. 4. Pregnant women, breastfeeding women, or women who may be pregnant. 5. Patients who have previously participated in a clinical trial of MSA-01.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in UMSARS Part 2 score at Week 52 after administration of the investigational drug. | — |
Contacts
Public ContactIkue Wada
The University of Tokyo Hospital
Outcome results
None listed