Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
Lead Sponsor:
Pfizer
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
Brief Summary
This study will be an open label, dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses given over 21 days (Day 3...
Eligibility Criteria
Inclusion
- Clinical diagnosis of idiopathic Parkinson's Disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia)
- Mini-Mental State Examination (MMSE) ≥ 25
- Hoehn \& Yahr Stage I-III inclusive
- Documented history of end of L-Dopa wearing OFF
- Cohort 5 only: History of dyskinesia following L-Dopa dosing and Score of at least 2 on Part IV, item 4.2 (functional impact of dyskinesia) of the MDS-UPDRS
Exclusion
- Atypical/secondary parkinsonism
- History of surgical intervention for Parkinson's Disease
- Dementia/cognitive impairment that can interfere with study assessments
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02224664
Start Date
October 1 2014
End Date
March 1 2016
Last Update
March 27 2017
Active Locations (17)
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1
Orange Coast Memorial Medical Center
Fountain Valley, California, United States, 92708
2
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
3
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
4
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States, 80113