Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
NCT ID: NCT02847650
Last Updated: 2020-11-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
57 participants
INTERVENTIONAL
2016-10-17
2018-01-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
PF-06649751
PF-06649751
Interventions
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Placebo
PF-06649751
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
80 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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St Joseph's Hospital and Medical Center, Barrow Neurology Clinics
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, United States
University of South Florida Faculty Office Building
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
University of South Florida Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Asheville Neurology Specialists PA
Asheville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
AS Clinical Research Consultants of North Texas, PLLC
Greenville, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, United States
Hopital Henri Mondor
Créteil, , France
Hôpital Henri Mondor
Créteil, , France
CHU de Grenoble Alpes
Grenoble, , France
CHU Grenoble Alpes
La Tronche, , France
Hospital de La Timone
Marseille, , France
Hospital La Timone
Marseille, , France
Hopital Pitie Salpetriere
Paris, , France
Hopital Pitie-Salpetriere
Paris, , France
St. Josef Hospital GmbH
Bochum, North Rhine-Westphalia, Germany
Praxis Oehlwein Outpatient clinic for PD, DBS, Movement Disorders
Gera, , Germany
Klinik Haag i. OB
Haag I. OB, , Germany
Paracelsus-Elena-Klinik Kassel
Kassel, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , Germany
University hospital Tuebingen
Tübingen, , Germany
Universitaetsklinik Ulm
Ulm, , Germany
Edith Wolfson Medical Center
Holon, , Israel
Pharmacy, Edith Wolfson Medical Center
Holon, , Israel
Countries
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References
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Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2016-001575-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7601011
Identifier Type: -
Identifier Source: org_study_id