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A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy

A Phase 2, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Open-label, Parallel Group Extension Part to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Potential Efficacy of Multiple Doses of ONO-2808 in Patients With Multiple System Atrophy

NCT05923866•Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.

Detailed Description

The purpose of the study is to evaluate 3 doses of ONO-2808 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) changes in clinical outcome assessments (COA) and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ONO-2808.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (35)

The Parkinson's Movement and Disorder Institute

Fountain Valley, California, United States

University of Southern California

Los Angeles, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, United States

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

New Haven, Connecticut, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Norman Fixel Institute for Neurological Diseases - University of Florida

Gainesville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Key Dates

Start Date

September 22, 2023

Primary Completion Date

August 31, 2025

Completion Date

August 31, 2025

Last Updated

June 3, 2025

Enrollment

ACTUAL participants

Conditions

Multiple System Atrophy (MSA)

Interventions

ONO-2808

DRUG

Placebo

DRUG

PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK

NCT02778607

Progressive Supranuclear Palsy (PSP)Corticobasal Degeneration+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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