Multicenter Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy Safety and Tolerability of 36 weeks of treatment with NLY01 in Early-Stage Parkinson s Disease

Brief description of study

Parkinson’s disease is a condition that interferes with body movement. The condition usually worsens over time. Research suggests that inflammation in certain areas of the brain causes damage to those areas that contributes to the condition. The drug NLY01 reduces this damage in animals with a condition similar to Parkinson’s disease. NLY01 is an “experimental” drug. “Experimental” means that the drug being tested in this research study has not been approved by the US Food and Drug Administration (FDA) as a treatment for any condition. Patients with Parkinson’s disease who took a drug very similar to NLY01, called exenatide, had more improvement of symptoms than patients with Parkinson’s disease who took placebo (a substance made to look like exenatide but containing no active drug). Researchers want to learn more about whether NLY01 prevents worsening of Parkinson’s disease, especially when it is taken early before any standard treatment has started.

Clinical Study Identifier: s19-01669 Identifier: NCT04154072
Principal Investigator: Andrew S. Feigin.
Other Investigator: Christine M. Stahl.

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