MSA-01 in Multiple System Atrophy
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study of MSA-01 in Patients With Multiple System Atrophy
Tokyo University
140 participants
Feb 9, 2026
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate whether MSA-01 slows the progression of multiple system atrophy (MSA) and to assess its safety. The primary question is: • Does MSA-01 slow the progression of motor impairment as measured by UMSARS Part 2 score? Participants will be randomly assigned to receive MSA-01 or placebo for 12 months. They will attend regular clinic visits for safety and efficacy assessments and record their medication use and any side effects in a diary.
Eligibility
Inclusion Criteria6
- At the time of informed consent
- Patients diagnosed as 'clinically established' or 'clinically probable' MSA based on the revised MSA diagnostic criteria of the Movement Disorder Society (MDS).
- Patients who are able to walk independently or with the use of assistive devices.
- Patients who are able to attend outpatient visits at the participating study site.
- At the start of study drug administration
- Patients who are able to discontinue the use of CoQ10 supplements.
Exclusion Criteria5
- Patients with severe neurological disorders, other progressive movement disorders, or cognitive impairment.
- Patients with severe liver disease.
- Patients with a known history of hypersensitivity to any component of the investigational drug.
- Pregnant women, breastfeeding women, or women who may be pregnant.
- Patients who have previously participated in a clinical trial of MSA-01.
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Interventions
Ubiquinol
Placebo
Locations(12)
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NCT07446894