Clinical Trial Details

Overview

Research Study Summary

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Purpose

Parkinson’s disease affects about 1 million people in the United States. Up to 50% of those affected experience daily changes in performing motor activities, called “OFF” episodes. These include periods of time where your medication wears off before the next dose and your Parkinson’s disease symptoms return, a delay in the response to your Parkinson’s disease medications, a partial response to your Parkinson’s disease medications or when your Parkinson’s disease medications suddenly, unexpectedly stop working. This study is evaluating the efficacy, safety and tolerability of a drug called APL-130277, a fast-acting thin film formulation of apomorphine that is placed under the tongue and is intended to be an alternative to the injectable form of apomorphine in patients with PD who experience motor fluctuations (“OFF” episodes).

To Learn more

CW ID: 216052
Date Last Changed: June 14, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Cynapsus Therapeutics
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria1.
  • Clinically meaningful response to Levodopa (L-Dopa).
  • Receiving stable doses of L-Dopa/carbidopa (immediate or chronic release [CR]) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit (SV1).
  • Patients must experience at least one well defined “OFF” episode per day with a total daily “OFF” time duration of ≥ 2 hours during the waking day.
  • Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
  • Mini–Mental State Examination (MMSE) score > 25.

Contact

Leigh Donharl
University of South Florida - USF Health Byrd Alzheimer's Institute
4001 Fletcher Avenue
Tampa, FL 33613
Phone: 813-396-0763

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