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New hope for rare brain disorder: drug trial targets MSA

NCT ID NCT05923866

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study tests an experimental drug called ONO-2808 in people with multiple system atrophy (MSA), a rare and serious brain disease. About 92 participants will receive either the drug or a placebo daily for up to 80 weeks. The goal is to see if the drug is safe and might help control symptoms or slow the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ONO-2808 (an oral drug)
What this could lead to
If successful, this could point toward a treatment that slows or eases symptoms of multiple system atrophy, a rare and severe neurological disorder.
What could go wrong
This is an early Phase 2 trial with only 92 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

92 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

30 to 80 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: 1. Female or male patients with a diagnosis of clinically-established or clinically-probable MSA according to the novel Movement Disorder Society (MDS) criteria for MSA diagnosis (2022), including patients with MSA of either subtype (MSA-P or MSA-C). 2. Patients at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA: * Parkinsonism * Ataxia * Orthostatic hypotension and/or urinary dysfunction 3. Patients with an anticipated survival of at least 3 years in the opinion of the Investigator. 4. Patients who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. Use of assistive devices (e.g., walker or cane) is allowed. 5. Ability to swallow oral medication and be willing to adhere to the study intervention regimen. Exclusion Criteria: 1. Pregnant or lactating females. 2. Patients with a clinically-significant or unstable medical or surgical condition other than MSA that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (e.g., pulmonary, cardiovascular \[including bradyarrhythmia\], macular edema, and significant renal or hepatic dysfunction). 3. Neurological diseases/disorders other than MSA, such as Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or post-encephalitic parkinsonism. 4. Patients with documented liver diseases or cirrhosis. 5. Positive results at Screening for active viral infections that include positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis B core antibody, and hepatitis C virus (HCV). 6. Patients with suicide ideation according to the Investigator's clinical judgment per the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or who have made a suicide attempt in the 6 months before Screening.

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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)

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University

    New York, New York, 10032, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30329, United States

  • Evergreen Health

    Kirkland, Washington, 98034, United States

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, Japan

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10019, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224, United States

  • NYU Langone Health - NYU Dysautonomia Center

    New York, New York, 10016, United States

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka, Osaka, Japan

  • National Hospital Organization Sendai Nishitaga Hospital

    Sendai, Miyagi, Japan

  • National Hospital Organization Utano National Hospital

    Kyoto, Kyoto, Japan

  • Norman Fixel Institute for Neurological Diseases - University of Florida

    Gainesville, Florida, 32608, United States

  • Ohio State University

    Columbus, Ohio, 43201, United States

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486, United States

  • Penn State University - Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Stanford University School of Medicine

    Palo Alto, California, 94304, United States

  • Swedish Neuroscience Institute, Movement Disorders Clinic

    Seattle, Washington, 98122, United States

  • The Parkinson's Movement and Disorder Institute

    Fountain Valley, California, 92708, United States

  • The University of Pennsylvania - Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Tokyo Metropolitan Neurological Hospital

    Fuchū, Tokyo, Japan

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Michigan School of Medicine

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298, United States

  • Yale School of Medicine - Yale Church Street Research Unit (CRSU)

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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