Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
NCT ID: NCT02197130
Last Updated: 2017-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2014-09-30
2016-10-31
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
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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20 mg PF-02545920 BID
20 mg PF-02545920 BID
PF-02545920
20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.
5 mg PF-02545920 BID
5 mg PF-02545920 BID
PF-02545920
5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.
Placebo BID
Matching placebo
Placebo
Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.
Interventions
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PF-02545920
20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.
PF-02545920
5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.
Placebo
Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.
Eligibility Criteria
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Inclusion Criteria
* Total motor score equal or greater than 10;
* Total functional capacity equal or greater than 7.
Exclusion Criteria
* Other severe acute psychiatric conditions, mania and/or psychosis;
* History of neutropenia, and myeloproliferative disorders;
30 Years
65 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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The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of California, Irvine
Irvine, California, United States
Ronald Regan UCLA Medical Center Drug Information Center
Los Angeles, California, United States
UCLA Neurology Clinic
Los Angeles, California, United States
UCLA Radiology
Los Angeles, California, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Albany Medical College
Albany, New York, United States
Wake Forest Baptist Medical Center - Dept. of Neurology
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation Hospital Pharmacy
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Davis Medical Center
Columbus, Ohio, United States
The Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
The Centre for Huntington Disease
Vancouver, British Columbia, Canada
Centre for Movement Disorders
Toronto, Ontario, Canada
CHUM-Notre-Dame Hospital
Montreal, Quebec, Canada
CHUM Notre Dame, Pharmacie
Montreal, Quebec, Canada
Technische Universität München
München, Bavaria, Germany
Uniklinik RWTH Aachen
Aachen, , Germany
Charite - Universitatsmedizin Berlin
Berlin, , Germany
Prof. Dr. Carsten Saft
Bochum, , Germany
Friedrich-Alexander-Universität
Erlangen, , Germany
Prof. Dr. med. Stephan Klebe
Freiburg im Breisgau, , Germany
Universitat zu Lubeck
Lübeck, , Germany
Philipps Universitat Marburg
Marburg, , Germany
George Huntington Institut
Münster, , Germany
Kbo-Isar-Amper-Klinikum gGmbH
Taufkirchen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Universitatsklinikum Wuerzburg
Würzburg, , Germany
Copernicus Podmiot Leczniczy sp. z o.o.
Gdansk, , Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
NHS Grampian, Clinical Genetics Centre
Aberdeen, Aberdeenshire, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Birmingham & Solihull Mental Health NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
John Van Geest Centre for Brain Repair
Cambridge, , United Kingdom
University of Wales Hospital
Cardiff, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Clinical Research Facility
London, , United Kingdom
University College London Hospitals Huntington's Disease Research Centre
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
The National Institute for Health Research/Wellcome Trust Clinical Research Facility
Manchester, , United Kingdom
St Nicholas Hospital
Newcastle upon Tyne, , United Kingdom
Newcastle Magnetic Resonance Centre
Newcastle upon Tyne, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-001291-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8241021
Identifier Type: -
Identifier Source: org_study_id