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
Status: Active_not_recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:
• 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).
• 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:
• Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
• 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.
• Ability to swallow oral medication and be willing to adhere to the study intervention regimen.
Locations
United States
California
The Parkinson's Movement and Disorder Institute
Fountain Valley
David Geffen School of Medicine at UCLA
Los Angeles
University of Southern California
Los Angeles
Stanford University School of Medicine
Palo Alto
Colorado
CenExel Rocky Mountain Clinical Research
Englewood
Connecticut
Yale School of Medicine - Yale Church Street Research Unit (CRSU)
New Haven
Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton
Norman Fixel Institute for Neurological Diseases - University of Florida
Gainesville
Mayo Clinic in Florida
Jacksonville
University of Miami Miller School of Medicine
Miami
Georgia
Emory University School of Medicine
Atlanta
Kansas
University of Kansas Medical Center Research Institute
Kansas City
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Michigan
University of Michigan School of Medicine
Ann Arbor
Quest Research Institute
Farmington Hills
Minnesota
Mayo Clinic - Rochester
Rochester
Nebraska
University of Nebraska Medical Center
Omaha
New York
Columbia University
New York
Icahn School of Medicine at Mount Sinai
New York
NYU Langone Health - NYU Dysautonomia Center
New York
Ohio
University of Cincinnati College of Medicine
Cincinnati
Cleveland Clinic
Cleveland
Ohio State University
Columbus
Pennsylvania
Penn State University - Milton S. Hershey Medical Center
Hershey
The University of Pennsylvania - Pennsylvania Hospital
Philadelphia
Texas
UT Southwestern Medical Center
Dallas
Virginia
Virginia Commonwealth University Medical Center
Richmond
Washington
Evergreen Health
Kirkland
Swedish Neuroscience Institute, Movement Disorders Clinic
Seattle
Other Locations
Japan
Tokyo Metropolitan Neurological Hospital
Fuchū
National Hospital Organization Utano National Hospital
Kyoto
National Hospital Organization Sendai Nishitaga Hospital
Sendai
Fujita Health University Hospital
Toyoake
National Hospital Organization Osaka Toneyama Medical Center