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MSA-01 in Multiple System Atrophy

RecruitingPhase 3Ages 30 Years - 79 YearsAllTokyo University
NCT07446894 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: 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.
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What it tests

  • MSA-01
  • Placebo
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Where

12 sites
Nagoya University Hospital
Nagoya, Japan
Chiba University Hospital
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Japan
Kagoshima University Hospital
Kagoshima, Japan
Kyoto University Hospital
Kyoto, Japan
Okayama University Hospital
Okayama, Japan
NHO Higashisaitama National Hospital
Hasuda, Japan

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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