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RECRUITING
NCT07446894
PHASE3

MSA-01 in Multiple System Atrophy

Sponsor: Tokyo University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study of MSA-01 in Patients With Multiple System Atrophy

Key Details

Gender

All

Age Range

30 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-02-09

Completion Date

2028-03-31

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

MSA-01

Ubiquinol

DRUG

Placebo

Placebo

Locations (12)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Chiba University Hospital

Chiba, Chiba, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

NHO Higashisaitama National Hospital

Hasuda, Saitama, Japan

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

National Center Hospital, National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan