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)
Brief description of study
The purpose of this clinical research study is to look at the safety and tolerability of the investigational study drug, ONO-2808, and whether it works when given to people with Multiple System Atrophy (MSA). MSA is a rare nervous system disease that can affect movement, balance, speech, blood pressure, bladder, and digestive function. Currently there is no FDA approved treatment for MSA, ONO-2808 may have the potential to reduce the a-synuclein (mis-folded a-synuclein is the protein which is believed to be the cause of MSA) in the central nervous system (CNS). ONO-2808 may promote nerve healing which, can lead to slowing of disease progression and provided symptomatic improvement.
The study will look at 3 different doses of the study drug, ONO-2808, compared to a placebo. ONO-2808
is an investigational drug which means it is not FDA approved and in this study is experimental.
The purpose of this clinical research study is to:
- Look at how tolerable the study drug, ONO-2808, is
- Whether it works when given to people with MSA
- What doses of the study drug are well tolerated
- How the study drug behaves inside the human body
This is a Phase 2 study. Phase 2 studies test whether or not a potential new drug works. The study drug will have been already tested in healthy volunteers. This is the first study of ONO-2808 in MSA patients.
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