A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy
NCT ID: NCT05923866
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
92 participants
INTERVENTIONAL
2023-09-22
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ONO-2808 Arm
ONO-2808
Oral administration of ONO-2808 at low, middle or high doses once a daily for 24 weeks
Placebo Arm
Placebo
Oral administration of placebo once a daily for 24 weeks
Interventions
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ONO-2808
Oral administration of ONO-2808 at low, middle or high doses once a daily for 24 weeks
Placebo
Oral administration of placebo once a daily for 24 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
80 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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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 Sendai Nishitaga Hospital
Sendai, Miyagi, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka, Osaka, Japan
Tokyo Metropolitan Neurological Hospital
Fuchū, Tokyo, Japan
National Hospital Organization Utano National Hospital
Kyoto, , Japan
Countries
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Other Identifiers
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jRCT2041230153
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-2808-03
Identifier Type: -
Identifier Source: org_study_id
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