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ACTIVE NOT RECRUITING

NCT05923866

PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-09-22

Completion Date

2027-01-01

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Multiple System Atrophy (MSA)

Interventions

DRUG

ONO-2808

Oral administration of ONO-2808 at low, middle or high doses once a daily for 24 weeks in the core part and 80 weeks total including the extension part

DRUG

Placebo

Oral administration of placebo once a daily for 24 weeks in the core part and 32 weeks total including the extension part; Transition to low-dose of ONO-2808 for remainder of the extension part until week 80

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

Emory University School of Medicine

Atlanta, Georgia, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan School of Medicine

Ann Arbor, Michigan, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYU Langone Health - NYU Dysautonomia Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Penn State University - Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

The University of Pennsylvania - Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Evergreen Health

Kirkland, Washington, United States

Swedish Neuroscience Institute, Movement Disorders Clinic

Seattle, Washington, United States

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

National Hospital Organization Utano National Hospital

Kyoto, Kyoto, Japan

National Hospital Organization Sendai Nishitaga Hospital

Sendai, Miyagi, Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka, Osaka, Japan

Tokyo Metropolitan Neurological Hospital

Fuchū, Tokyo, Japan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (35)