Lenrispodun

Purpose

The purpose of this study is to compare the efficacy of lenrispodun 30 mg, administered once daily as adjunctive therapy to stable doses of existing levodopa therapy, with that of placebo as adjunctive therapy to stable doses of existing levodopa therapy in patients with motor fluctuations due to Parkinson’s disease (PD). This comparison will be measured by the change from baseline to Day 29 in daily ON time without troublesome dyskinesia (i.e., daily total ON time without dyskinesia and ON time with non-troublesome dyskinesia), based on the 3-day average of the Hauser Diary.

Who Can Participate

Patients who satisfy the requirements listed below are eligible to participate:

• Male or female between 40 and 80 years of age
• Diagnosis of Parkinson’s disease (PD)
• Hoehn & Yahr (H&Y) stage 2 or 3 when in the ON state
• On a stable dose of levodopa (levodopa + dopa-decarboxylase inhibitor [DDCI] combination, minimum dose 100 mg TID) for at least 4 weeks
• Has wearing-off symptoms and levodopa-induced dyskinesia
• Not currently on ASA (acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs)
• Willing and able to complete 3-day Hauser diaries
• Willing and able to collect stool samples prior to visits

Visits

This study requires 6 in person visits over 9 weeks, with the total study duration being nine weeks.

Principal Investigator: Holly Shill, MD