Parkinson's Disease Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
This multi-center, Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover,
Positive Control study designed to evaluate the QT interval prolongation potential of 10 mg
to 60 mg doses of APL-130277 compared to placebo and the positive control, 400mg moxifloxacin
in subjects with Parkinson's Disease (PD) who experience motor fluctuations ("OFF" episodes)
The patient is titrated to the highest tolerated dose from 10mg to 60mg, and then is
randomized to one of six crossover sequences. Each sequence includes treatment with the
following:
1. Treatment A: APL-130277 at the dose determined in the Dose Titration Phase,
2. Treatment B: Matched placebo,
3. Treatment C: A single 400 mg dose of moxifloxacin
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