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)
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).
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CW ID: 216052
Date Last Changed:
June 14, 2016
Clinical Trial Snapshot
- Both Male and Female
- 18 and up
- Overall Status
- Cynapsus Therapeutics
- Facility Type
- 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.
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