Open-Label Study of the Effects and Safety of APL-130277 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 all subjects will receive APL-130277.

Who we are studying

  • Men and Women
  • Races:
    • White
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • To participate you must be:
    • -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 Also to participate you must NOT have
    • -Underwent any surgery for Parkinson's Disease

What is involved

  • In the study
  • You would have: your vital signs taken
  • Physical exams
  • Blood and urine collections
  • Questionnaires
  • Parkinson's Disease assessments
  • Ecgs (to check your heart). There will be approximately 13 in-clinic visit and 3 telephone calls.

Compensation

There will be compensation for completed visits.

Contact Information

Study Coordinator
Jessica Dimos
Email
jdimos@wakehealth.edu
Phone
336-716-8694
Principal Investigator
Mustafa Siddiqui, MD

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.