MSA-01 in Multiple System Atrophy
Recruiting
Phase 3
Interventional Study
Multiple System Atrophy (MSA)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 – 79
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Tokyo University · Other
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About This Trial
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 efficac…
Trial Locations
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Eligibility 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 device…
Contacts