Clinical Trials in Japan / NCT07446894
Recruiting
Phase 3
MSA-01 in Multiple System Atrophy
NCT07446894 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Multiple System Atrophy (MSA)
Investigational drug(s) / intervention(s)
MSA-01Placebo
MSA-01: Ubiquinol
Placebo: Placebo
Study 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 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.
Primary outcome measure(s)
- Change from baseline to Week 52 in the Unified Multiple System Atrophy Rating Scale (UMSARS) Part 2 score — Baseline to Week 52
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | Not Yet Recruiting |
| Chiba University Hospital | Chiba | Chiba | Not Yet Recruiting |
| Kyushu University Hospital | Fukuoka | Fukuoka | Not Yet Recruiting |
| Hokkaido University Hospital | Sapporo | Hokkaido | Not Yet Recruiting |
| Kagoshima University Hospital | Kagoshima | Kagoshima-ken | Not Yet Recruiting |
| Kyoto University Hospital | Kyoto | Kyoto | Not Yet Recruiting |
| Okayama University Hospital | Okayama | Okayama-ken | Not Yet Recruiting |
| NHO Higashisaitama National Hospital | Hasuda | Saitama | Not Yet Recruiting |
| Institute of Science Tokyo Hospital | Bunkyō-Ku | Tokyo | Not Yet Recruiting |
| The University of Tokyo Hospital | Bunkyō-Ku | Tokyo | Recruiting |
| National Center Hospital, National Center of Neurology and Psychiatry | Kodaira | Tokyo | Not Yet Recruiting |
| Tottori University Hospital | Yonago | Tottori | Not Yet Recruiting |
More Tokyo University trials in Japan
Other trials for the same condition
A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07446894 on ClinicalTrials.gov ↗ ← All trials in Japan