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

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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.

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.

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
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Asheville, North Carolina 28806
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Atlanta, GA
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Boca Raton, FL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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51 Avenue du Maréchal de Lattre de Tassigny
CRÉTEIL Cedex, 94010
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CRÉTEIL Cedex,
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Greenville, TX
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Phoenix, AZ
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Tampa, FL
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13220 USF Laurel Drive
Tampa, Florida 33612
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3000 Arlington Avenue
Toledo, Ohio 43614
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Virginia Beach, Virginia 23456
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