Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
NCT ID: NCT02342548
Last Updated: 2018-04-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
188 participants
INTERVENTIONAL
2015-02-25
2017-02-06
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
TREATMENT
NONE
Study Groups
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20 mg BID PF-02545920 non-titrated
Subjects who received 20 mg BID in completed study A8241021 will continue to receive 20 mg BID PF-02545920
20 mg BID of PF-02545920
All subject who completed A8241021 will receive 20 mg BID (with or without titration)
20mg BID PF-02545920 titrated
Subjects who received either Placebo or 5mg BID of PF-02545920 in completed study A8241021 will be titrated up to 20 mg with 5mg increment per week, over 4 weeks (5mg increment/wk)
20 mg BID of PF-02545920
All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Interventions
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20 mg BID of PF-02545920
All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of HD, including ≥36 CAG repeats.
Exclusion Criteria
* WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or myeolo-proliferative disorders.
* Any drug related SAE experienced during study A8241021 which were not approved as acceptable for enrollment in A8241022.
30 Years
66 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 Kirkland Clinic of UAB Hospital
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of California, Irvine
Irvine, California, United States
Ronald Reagan 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 & Neurorestoration
Gainesville, Florida, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 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
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
The Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
The Wright Center of Innovation- The Ohio State University
Columbus, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
The Centre For Huntington Disease, The University of British Columbia
Vancouver, British Columbia, Canada
Center For Movement Disorders
Toronto, Ontario, Canada
CHUM-Notre-Dame Hospital
Montreal, Quebec, Canada
CHUM-Notre-Dame, Pharmacie
Montreal, Quebec, Canada
Uniklinik RWTH Aachen
Aachen, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
St. Josef Hospital
Bochum, , Germany
Friedrich-Alexander-Universität
Erlangen, , Germany
Universität zu Lübeck
Lübeck, , Germany
Philipps Universitat Marburg
Marburg, , Germany
Technische Universität München
München, , Germany
George-Huntington-Institut
Münster, , Germany
Kbo-Isar-Amper-Klinikum gGmbH
Taufkirchen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Copernicus Podmiot Leczniczy sp.zo.o
Gdansk, , Poland
Krakowska Akademia Neurologii Sp. zo.o
Krakow, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Instytut Psychiatrii i Neurologii, I Klinika Neurologiczna
Warsaw, , Poland
Central Manchester University Hospitals NHS Foundation Trust
Oxford Road, Manchester, United Kingdom
St Nicholas Hospital
Gosforth, Newcastle UPON TYNE, United Kingdom
Bimingham & Solihull Mental Health NHS Foundation Trust Department of Neuropsychiatry
Birmingham, WEST Midlands, United Kingdom
NHS Grampian, Aberdeen Royal Infirmary, Clinical Genetics Centre
Aberdeen, , United Kingdom
Institute of Psychological Medicine and Clinical Neurosciences
Cardiff, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, , United Kingdom
University College London Hospitals Huntington's Diesease
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
The National Institute for Health Research / Wellcome Trust Clinical Research Facility
Manchester, , United Kingdom
Newcastle Magnetic Resonance Centre
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Wessex Neurological Centre
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-004900-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OPEN LABEL TO A8241021
Identifier Type: OTHER
Identifier Source: secondary_id
A8241022
Identifier Type: -
Identifier Source: org_study_id
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