Objective: To assess the effect of apomorphine sublingual film (APL130277; APL) on the QT interval in patients with Parkinson’s disease (PD) and “OFF” episodes participating in a Phase 2, randomized, double-blind, placebo-controlled study.

Background: APL was found to be effective and generally well tolerated as an acute, intermittent treatment for “OFF” episodes in patients with PD in a controlled Phase 3 trial. No previous study has reported the effects of apomorphine on QT interval.

Method: Adult patients with PD and “OFF” episodes, no cardiac abnormalities, and no antiemetic use on stable PD medications were eligible. Forty patients were randomized to a single dose of APL (dose determined during titration), matching placebo, and moxifloxacin (positive control; 400 mg) in a 3-way crossover design. Time-matched changes from baseline in the placebo-adjusted QT interval corrected using Fridericia’s formula (Delta Delta QTcF),  were calculated from electrocardiograms taken at 0.25, 0.5, 0.75, 1, 2, 3, and 4 hours postdose. Baseline was defined as the mean of 9 predose measurements.

Results: The lower limit of the Bonferroni-corrected 90% confidence intervals for the moxifloxacin-placebo comparison was above the 5 ms threshold at 3 of the 4 prespecified timepoints, demonstrating adequate sensitivity to assess QT interval corrected for heart rate prolongation.

Conclusion: This is the first study to evaluate apomorphine delivered as a sublingual film on QT interval and other parameters of cardiac conduction in patients with PD and “OFF” episodes. The results from these analyses will be subsequently presented.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-thorough-qt-study-of-apomorphine-sublingual-film-in-patients-with-parkinsons-disease-complicated-by-off-episodes/