Testing Two Doses of AP-472 Added to Levodopa for Parkinsons Disease Motor Fluctuations in a Phase 2 Double-Blind Study

What this Trial Is About

Researchers are evaluating the effectiveness of two different doses of the drug AP-472 as an add-on treatment to levodopa in people with Parkinsons disease who experience motor fluctuations. This Phase 2 study aims to compare the effects of AP-472 at 100 mg and 300 mg per day against a placebo. Participants will be adults aged 30 to 80 years with mild to moderate Parkinsons disease and specific motor symptoms. Participants will be randomly assigned to receive either a low dose of AP-472, a high dose of AP-472, or a placebo. The study is double-blind, meaning neither participants nor study staff will know who receives which treatment. The study includes a screening period, followed by a 4-week period where Parkinsons medications must remain stable, and then an 8-week treatment period during which limited adjustments to levodopa are allowed if needed. During the study, participants will complete motor diaries to track their symptoms, and researchers will assess changes in daily OFF time and other Parkinsons disease-related scales and questionnaires. The main measurement is the change in average daily OFF time after 12 weeks. Safety and efficacy will be monitored throughout the study, which lasts about 12 weeks in total.

A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations