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

NCT07825402 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ONO-2808-03-001
• Study Type: interventional
• Target: 486
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple System Atrophy, Parkinson Variant

Keywords

MSA-P; Parkinson's; Parkinsonian Subtype of; Parkinsonism; MSA; Multiple System Atrophy; Movement Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3)

  Baseline, Week 48

Secondary Outcomes (9)

• Change from Baseline in Multiple System Atrophy Quality of Life Scale (MSA-QoL) Motor Subscale Score

  Baseline, Week 48

• Change from Baseline in Magnetic Resonance Imaging (MRI) Volumetric Assessments

  Baseline, Week 48

• Change from Baseline in Total United Multiple System Atrophy Rating Scale (UMSARS) Score (Part I and Part II, all items)

  Baseline, Week 48

• Change from Baseline in mUMSARS Score

  Baseline, Week 48

• Change from Baseline in MSA-QoL Total Score

  Baseline, Week 48

Study Arms (3)

ONO-2808 Low Dose

EXPERIMENTAL

Drug: ONO-2808

ONO-2808 High Dose

EXPERIMENTAL

Drug: ONO-2808

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

ONO-2808 DRUG

ONO-2808 will be administered to participants orally once daily for 48 weeks.

ONO-2808 High Dose; ONO-2808 Low Dose

Placebo OTHER

Matching placebo will be administered to participants orally once daily for 48 weeks.

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead
• Deciphera Pharmaceuticals, LLC: collaborator

MeSH Terms

Conditions

Multiple System Atrophy; Parkinson Disease; Parkinsonian Disorders; Movement Disorders

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Clinical Team

  Ono Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274; clinicaltrials@deciphera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share