Study Title: (CTH-300) A Phase 3 Study to Examine the Efficacy, Safety and Tolerability of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
ClinicalTrails.gove Identified: NCT02469090
Clinical Trial Investigator: Cindy Zadikoff, MD
A 12-week prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("off" episodes), designed to determine the efficacy, safety and tolerability of APL=130277 (sublingual apomorphine thin films). Patients who complete the study will be eligible for the 24 week Open Label study (CTH-301) to determine the long-term safety, tolerability, and efficacy of APL-130277.
Clinical Trial Eligibility Criteria:
- Diagnosis of Parkinson's Disease
- Stable doses of levodopa/carbidopa ≥4 / day or Rytary (TM) 3x / day for ≥ 4 wks before the first visit
- On stable dose of PD medication regimens for ≥ 4 wks (some require ≥ 8 wks) before initial visit
- Must experience symptoms related to the wearing off of medications at least once per day.
Study Visits: 13 Clinic Visits & 4 telephone follow-ups (over 12 wks)
Treatment: APL-130277 (sublingual apomorphine thin films) or Placebo
Compensation: $50 for each visit
IRB#: Project: STU00201467
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