Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Status: | Terminated |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 45 - 80 |
Updated: | 1/17/2019 |
Start Date: | October 17, 2016 |
End Date: | January 29, 2018 |
A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Flexible Dose Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Early Stage Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751
in Parkinson's disease patients at early stage of the disease.
in Parkinson's disease patients at early stage of the disease.
The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design.
Approximately 88 subjects will be randomized to 2 treatment groups. Each subject will
participate in the study for approximately 23 weeks including a 30 day screening period, 15
week double blind treatment period, and an approximately 28 day follow-up period.
Approximately 88 subjects will be randomized to 2 treatment groups. Each subject will
participate in the study for approximately 23 weeks including a 30 day screening period, 15
week double blind treatment period, and an approximately 28 day follow-up period.
Inclusion Criteria:
- Females of non-childbearing potential and/or male subjects
- Clinical diagnosis of Parkinson's disease.
- Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
- Treatment naïve or history of prior incidental treatment with dopaminergic agents for
no more than 28 days
- Able to refrain from any Parkinson's disease medication not permitted by the protocol.
Exclusion Criteria:
- History or presence of atypical Parkinsonian syndrome.
- Severe acute or chronic medical or psychiatric condition or cognitive impairment or
laboratory abnormality.
- Any condition possibly affecting drug absorption.
- Participation in other studies involving investigational drug(s), or treatment with
any investigational drug within 30 days.
We found this trial at
21
sites
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Miami A private research university with more than 15,000 students from around the...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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12901 Bruce B Downs Boulevard
Tampa, Florida 33612
Tampa, Florida 33612
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University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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