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A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes

  • STATUS
    Not Recruiting
  • participants needed
    48
  • sponsor
    Sumitomo Pharma America, Inc.
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Updated on 22 July 2024
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Summary

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)

Description

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

Details
Condition Parkinson's Disease, Off Episodes of Parkinson Disease
Age 18years or above
Treatment Placebo, Moxifloxacin, APL-130277
Clinical Study IdentifierNCT03187301
SponsorSumitomo Pharma America, Inc.
Last Modified on22 July 2024

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