PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 45 - 85 |
Updated: | 5/5/2016 |
Start Date: | November 2015 |
End Date: | May 2016 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.
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.
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.
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.
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