Actively Recruiting

Phase 3
Age: 30Years - 79Years
All Genders
NCT07446894

MSA-01 in Multiple System Atrophy

Led by Tokyo University · Updated on 2026-03-04

140

Participants Needed

12

Research Sites

111 weeks

Total Duration

On this page

Sponsors

T

Tokyo University

Lead Sponsor

N

Nobelpharma

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MSA-01 in Multiple System Atrophy

Who Can Participate

Age: 30Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed as clinically established or clinically probable multiple system atrophy based on revised Movement Disorder Society criteria
  • Able to walk independently or with assistive devices
  • Able to attend outpatient visits at the study site
  • Able to stop taking coenzyme Q10 supplements before starting study drug
Not Eligible

You will not qualify if you...

  • Having severe neurological disorders, other progressive movement disorders, or cognitive impairment
  • Having severe liver disease
  • Known allergy to any component of the study drug
  • Pregnant, breastfeeding, or possibly pregnant women
  • Previous participation in an MSA-01 clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Not Yet Recruiting

2

Chiba University Hospital

Chiba, Chiba, Japan

Not Yet Recruiting

3

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Not Yet Recruiting

4

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Not Yet Recruiting

5

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Not Yet Recruiting

6

Kyoto University Hospital

Kyoto, Kyoto, Japan

Not Yet Recruiting

7

Okayama University Hospital

Okayama, Okayama-ken, Japan

Not Yet Recruiting

8

NHO Higashisaitama National Hospital

Hasuda, Saitama, Japan

Not Yet Recruiting

9

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

Not Yet Recruiting

10

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

Actively Recruiting

11

National Center Hospital, National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Not Yet Recruiting

12

Tottori University Hospital

Yonago, Tottori, Japan

Not Yet Recruiting

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Research Team

J

Jun Mitsui

CONTACT

I

Ikue Wada

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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MSA-01 in Multiple System Atrophy | DecenTrialz