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PF-06669571 In Subjects With Idiopathic Parkinson's Disease
PF-06669571 In Subjects With Idiopathic Parkinson's Disease

NCT02565628

CompletedPhase 1

Sponsor: Pfizer

Conditions: Idiopathic Parkinson's Disease

Interventions: PF-06669571, Placebo

Countries: United States

This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.

Eligibility overview

Sex: ALL

Age: 45 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
* Must be Hoehn \& Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
* Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.

Exclusion Criteria:

\- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Locations (9)
  • New Haven, Connecticut, United States
  • Hallandale, Florida, United States
  • Hollywood, Florida, United States
  • South Miami, Florida, United States
  • South Miami, Florida, United States
  • South Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Marlton, New Jersey, United States
  • Cincinnati, Ohio, United States