臨床研究等提出・公開システム

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

MSA-01_03

Mitsui Jun

The University of Tokyo Hospital

7-3-1, Hongo, Bunkyo-ku, Tokyo

mituij-tky@g.ecc.u-tokyo.ac.jp

Wada Ikue

The University of Tokyo Hospital

7-3-1, Hongo, Bunkyo-ku, Tokyo

+81-3-5800-9762

msa-office@umin.ac.jp

Recruiting

Feb. 09, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Both

Multiple System Atrophy (MSA)

Administration of MSA 01 or placebo for 52 weeks.

Multiple System Atrophy

CoQ10

C10

Change in UMSARS Part 2 score at Week 52 after administration of the investigational drug.

+81-3-5800-8743

Nov. 18, 2025

No

none