Study of the Effects and Safety of APL-130277 Versus Placebo in Patients with Parkinson’s Disease Experiencing “OFF” Episodes

What we are studying

Cynapsus, the study sponsor, is developing the study 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. This study is designed to determine the effectiveness, safety, and tolerability of multiple treatments of APL-130277 in patients with Parkinson’s disease who experience OFF episodes. In this study APL-130277 will be compared to placebo.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • Hispanic or Latino
  • Ages 18+

Eligibility Criteria

  • Diagnosed with idiopathic Parkinson's Disease
  • Experience "OFF" episodes
  • Be taking sinemet (carbidopa/levidopa) at least 4 times daily
  • Medications must be stable for at least 4 weeks
  • You must NOT have underwent any surgery for Parkinson's Disease

What is involved

  • Vital signs taken
  • Physical exams
  • Blood and urine collections
  • Questionnaires
  • Parkinson's Disease assessments
  • Ecgs (to check your heart)
  • 12 in-clinic visit and 4 telephone calls

Compensation

There will be compensation for completed visits.

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.