ClinicalTrials.gov record NCT07825402

A Trial of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age30 years old to 80 years old
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 3 randomized, double-blind study compares two doses of oral ONO-2808 with matching placebo in people with the parkinsonian subtype of multiple system atrophy (MSA-P). Participants take the assigned study pill once daily for up to 48 weeks, attend clinic visits for checks and testing, and complete health and quality-of-life questionnaires. Main measurements include a modified MSA clinical rating scale at baseline and Week 48, with MRI and other clinical and patient-reported assessments as secondary outcomes.

What it is studying. The study tests ONO-2808 given daily (two dose levels) versus placebo over 48 weeks, measuring change in clinical rating scales, MRI brain volumes, and patient-reported outcomes in MSA-P.

What the researchers hope to learn. Primary scientific goal: evaluate change from baseline to Week 48 in the modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I score. Secondary goals include assessing effects on total UMSARS scores, MSA-Quality of Life (MSA-QoL) scores, MRI volumetric assessments, and global impression measures.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P. Participants will:

  • Take ONO-2808 or placebo orally for up to 48 weeks
  • Make visits to the clinic for checkups and tests
  • Answer questions about their health throughout the trial.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • ONO-2808
Other
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participants with a diagnosis of clinically established or clinically probable MSA-P according to the 2022 Movement Disorder Society (MDS) criteria for MSA diagnosis.
  • Participants in 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-P:
  • Parkinsonism
  • Orthostatic hypotension
  • Urinary dysautonomia
  • Participants with an anticipated survival of at least 3 years in the opinion of the Investigator.
  • Participants 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 (eg, walker or cane) is allowed.
  • Ability to swallow oral medication and willingness to adhere to the study drug regimen.
  • Normal range of laboratory values at screening and baseline, especially liver function tests.
  • Participants receiving treatment (including chronic medications, and herbal or dietary supplements) for symptoms associated with MSA must be on a stable dosage for at least 60 days prior to randomization based on the judgment of the Investigator. Participants must not initiate new treatment within 60 days prior to randomization.
  • Key

Exclusion criteria

  • Participants with the cerebellar subtype of MSA according to the 2022 MDS criteria for MSA diagnosis.
  • Female participants who are pregnant, planning to become pregnant during the study, or breastfeeding.
  • Participants with a clinically significant or unstable medical or surgical condition other than MSA-P that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (eg, pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).
  • Neurological diseases/disorders other than MSA-P, 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 postencephalitic parkinsonism.
  • Any abnormalities, other than MSA, found on the centrally read brain MRI that, in the opinion of the Investigator, may constitute a confounder for the study or preclude safe participation.
  • Participants with documented liver diseases, cirrhosis, prior drug-induced liver injury (DILI), or ascites or symptoms and signs of encephalopathy due to hepatic dysfunction.
  • Other protocol-defined inclusion and exclusion criteria apply.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will be randomly assigned to take ONO-2808 (low or high dose) or a matching placebo by mouth once daily for up to 48 weeks. You will make clinic visits for checkups and tests and complete clinical rating scales and questionnaires about symptoms and quality of life, with key measurements at baseline and Week 48. Brain MRI scans for volumetric assessments are done at baseline and at Week 48. The registry record does not list additional procedures, participant services, or the exact visit schedule.

How the study is structured. Phase 3, randomized, double-blind, placebo-controlled, parallel-group trial. Participants are assigned to one of three groups (ONO-2808 low dose, ONO-2808 high dose, or matching placebo) and take the assigned oral medication once daily for 48 weeks. Key outcomes are assessed at baseline and at Week 48.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
January 2027 (estimated)
Primary completion
October 2029 (estimated)
Study completion
October 2029 (estimated)
Target enrollment
486 participants (estimated)
Last updated on registry
Sep 17, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Ono Pharmaceutical Co., Ltd.
Collaborators
  • Deciphera Pharmaceuticals, LLC

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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