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Hope for MSA: new drug aims to slow rare brain disease

NCT ID NCT07446894

Disease control Sponsor: Tokyo University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called MSA-01 to see if it can slow the worsening of multiple system atrophy (MSA), a rare and serious brain disease. About 140 people with MSA will get either MSA-01 or a placebo for 12 months. The main goal is to measure changes in movement and daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple system atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple system atrophy (MSA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chiba University Hospital

    NOT_YET_RECRUITING

    Chiba, Chiba, Japan

  • Hokkaido University Hospital

    NOT_YET_RECRUITING

    Sapporo, Hokkaido, Japan

  • Institute of Science Tokyo Hospital

    NOT_YET_RECRUITING

    Bunkyō-Ku, Tokyo, Japan

  • Kagoshima University Hospital

    NOT_YET_RECRUITING

    Kagoshima, Kagoshima-ken, Japan

  • Kyoto University Hospital

    NOT_YET_RECRUITING

    Kyoto, Kyoto, Japan

  • Kyushu University Hospital

    NOT_YET_RECRUITING

    Fukuoka, Fukuoka, Japan

  • NHO Higashisaitama National Hospital

    NOT_YET_RECRUITING

    Hasuda, Saitama, Japan

  • Nagoya University Hospital

    NOT_YET_RECRUITING

    Nagoya, Aichi-ken, Japan

  • National Center Hospital, National Center of Neurology and Psychiatry

    NOT_YET_RECRUITING

    Kodaira, Tokyo, Japan

  • Okayama University Hospital

    NOT_YET_RECRUITING

    Okayama, Okayama-ken, Japan

  • The University of Tokyo Hospital

    RECRUITING

    Bunkyō-Ku, Tokyo, Japan

  • Tottori University Hospital

    NOT_YET_RECRUITING

    Yonago, Tottori, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.