PF-06669571 In Subjects With Idiopathic Parkinson's Disease
NCT ID: NCT02565628
Last Updated: 2023-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2015-11-16
2016-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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PF-06669571
Once daily (QD) for 7 days
PF-06669571
1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
Placebo
QD for 7 days
Placebo
Placebo
Interventions
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PF-06669571
1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
45 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
MD Clinical
Hallandale, Florida, United States
QPS-MRA, LLC (Broward Research Group)
Hollywood, Florida, United States
Qps-Mra Llc
South Miami, Florida, United States
QPS-MRA, LLC (Miami research Associates)
South Miami, Florida, United States
QPS-MRA, LLC (MRA Clinical Research)
South Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CRI Worldwide, LLC
Marlton, New Jersey, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Countries
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References
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Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.
Related Links
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Other Identifiers
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B7821002
Identifier Type: -
Identifier Source: org_study_id
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