Cynapsus Therapeutics initiates Phase III trial of APL 130277 for treatment of Parkinson's disease

Cynapsus Therapeutics announced enrolment of the first patient in the Phase III CTH-301 clinical trial of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease. CTH-300, a pivotal Phase III efficacy study, is also ongoing with data expected from both trials in 2016.

The CTH-301 trial is a 6-month, 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 primary endpoint for the study is the safety and tolerability of APL-130277 in patients with PD. The secondary endpoints examine efficacy variables including the change in the MDS-UPDRS Part III scores over the 6-months of treatment. Sites will recruit patients over several months, with each patient being evaluated for six months. 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.