MSA-01 in Multiple System Atrophy
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 79 years old?
Source: NCT07446894, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tokyo University
- Trial code
- NCT07446894
- Record updated
- 4 March 2026
- Original description
The purpose of this study is to evaluate whether MSA-01 slows the progression of multiple system atrophy (MSA) and to assess its safety.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study of MSA-01 in Patients With Multiple System Atrophy
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.
Inclusion: 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: Patients with a known history of hypersensitivity to any component of the investigational drug; Patients who have previously participated in a clinical trial of MSA-01; Patients with severe neurological disorders, other progressive movement disorders, or cognitive impairment; Patients with severe liver disease; Pregnant women, breastfeeding women, or women who may be pregnant.