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Abstracts from the International Congress of Parkinson’s and Movement Disorders.

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A Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson’s Disease Complicated By “OFF” Episodes

F. Stocchi, K. Wilks, E. Peckham, M. de Pandis, K. Sciarappa, F. Agbo, R. Kleiman, D. Blum, B. Navia (Rome, Italy)

Meeting: 2019 International Congress

Abstract Number: 1097

Keywords: Apomorphine, Parkinsonism, Wearing-off fluctuations

Session Information

Date: Tuesday, September 24, 2019

Session Title: Parkinsonisms and Parkinson-Plus

Session Time: 1:45pm-3:15pm

Location: Agora 3 West, Level 3

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.

To cite this abstract in AMA style:

F. Stocchi, K. Wilks, E. Peckham, M. de Pandis, K. Sciarappa, F. Agbo, R. Kleiman, D. Blum, B. Navia. A Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson’s Disease Complicated By “OFF” Episodes [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/a-thorough-qt-study-of-apomorphine-sublingual-film-in-patients-with-parkinsons-disease-complicated-by-off-episodes/. Accessed July 15, 2025.
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