At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 141 enrolled
Drug / intervention
APL-130277 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
In Brief
A Phase 3 clinical trial evaluating APL-130277 and Placebo for Parkinson Disease, Off Episodes. Completed, enrolled 141 participants across 33 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease, Off Episodes
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionDec 2017
TodayJul 2026
First PostedJun 11, 2015
Enrollment StartJun 18, 2015
Primary CompletionDec 11, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.1 years ago
Interventions
APL-130277drug
Use to treat up to 5 "OFF" episodes per day
Placebodrug
placebo