RecruitingPhase 3NCT07446894

MSA-01 in Multiple System Atrophy

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

Sponsor

Tokyo University

Enrollment

140 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple System Atrophy (MSA)

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

Min Age: 30 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MSA-01 and a drug called Placebo for people with multiple system atrophy (msa). The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMSA-01

Ubiquinol

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07446894

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