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

A Phase 3, 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)

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 18 - 100 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus: Bradykinesia (slowness of movement), rigidity, Tremors

Study Purpose:

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.

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More Details

Phase: Phase 3 Lead Sponsor: Sunovion
Trial ID: 004154 Sponsor Type: Industry
Country: United States Additional Collaborators or Sponsors:
Estimated Enrollment: 126 Study Start Date: June 2015
Estimated Study Completion Date: July 2017 Source: ClinicalTrials.gov
Study Website:
This is a FDA Regulated Trial

More Inclusion & Exclusion Criteria

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