A Phase 2 double-blind placebo-controlled parallel-group study to assess the safety tolerability pharmacokinetics pharmacodynamics and potential efficacy of multiple doses of ONO-2808 in patients with Multiple System Atrophy (MSA)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Multiple System Atrophy
  • Age: Between 30 Year(s) - 80 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participant must be 30 to 80 years of age inclusive, at the time of signing the informed consent.
    2. Female or male patients with a diagnosis of clinically-established or clinically-probable Multiple System Atrophy (MSA).
    3. 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
    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.

You may not be eligible for this study if the following are true:

    1. Pregnant or lactating females.
    2. Patients with a clinically-significant or unstable medical or surgical condition other than MSA that (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 or who have made a suicide attempt in the 6 months before Screening.
    7. History of electroconvulsive therapy and/or history of deep brain stimulation therapy.
    8. Regular use of neuroleptics within 6 months prior to the initial evaluation. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, providing not more than 3 doses were taken within the previous 12 months.



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