CURRENT CLINICAL TRIALS FOR APL-130277 FOR THE ACUTE TREATMENT OF OFF EPISODES IN PARKINSON’S DISEASE PATIENTS
CTH-300 PHASE 3 EFFICACY STUDY
A double-blind, placebo-controlled, parallel-design study with an estimated 126 PD patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. The objective is to evaluate the efficacy, safety and tolerability of APL-130277 versus placebo in patients with PD over a 12 week period. The primary end point will be the mean change in the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III) score at 30 minutes after dosing.
CTH-301 PHASE 3 SAFETY STUDY
A long-term open-label, single arm safety study in PD patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. The objective is to evaluate the safety and tolerability of APL-130277 in patients with PD over a six-month period. An estimated 226 patients will be enrolled, including up to 126 who had been enrolled in the CTH-300 efficacy study and rolled over to this study, plus an additional 100 new patients.