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Brief Title: 
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease

Study Description

This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5 mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized in the study. Primary endpoint is the change from baseline in the Total Motor
Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.

Study Type: 
Interventional
Organization ID: 
A8241021
Clinical Trial ID: 
NCT02197130
Completed
Study Start Date: 
September, 2014
Study End Date: 
October, 2016

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Criteria

Inclusion Criteria:

- CAG repeat equal or greater than 36;

- Total motor score equal or greater than 10;

- Total functional capacity equal or greater than 7.

Exclusion Criteria:

- Clinically significant neurologic disorder other than Huntington's disease;

- Other severe acute psychiatric conditions, mania and/or psychosis;

- History of neutropenia, and myeloproliferative disorders;

Gender: 
Both
30 Years - 65 Years
Healthy Volunteers Allowed: 
No
United States
For Drug Shipment only - The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
University of California, Irvine - Drug Shipment
Irvine, California, United States, 92697
University of California, Irvine
Irvine, California, United States, 92697
Ronald Regan UCLA Medical Center Drug Information Center - DRUG SHIPMENT ONLY
Los Angeles, California, United States, 90095
UCLA Neurology Clinic
Los Angeles, California, United States, 90095
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States, 80113
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Albany Medical College
Albany, New York, United States, 12208
Wake Forest Baptist Medical Center - Dept. of Neurology
Winston-Salem, North Carolina, United States, 27157
Drug Shipment Address - Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Davis Medical Center
Columbus, Ohio, United States, 43210
The Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States, 43221
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States, 43221
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada
The University of British Columbia, Centre for Huntington Disease
Vancouver, British Columbia, Canada, V6T 2B5
Center for Movement Disorders
Toronto, Ontario, Canada, M3B 2S7
CHUM-Notre-Dame Hospital
Montreal, Quebec, Canada, H2L 4M1
CHUM Notre Dame, Pharmacie (Drug Shipment only)
Montreal, Quebec, Canada, H4L 4M1
Germany
Technische Universität München
Munchen, Bavaria, Germany, 81675
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Charite - Universitatsmedizin Berlin
Berlin, Germany, 10117
St. Josef- und St Elisabeth Hospital GmbH
Bochum, Germany, 44791
Friedrich-Alexander-Universität
Erlangen, Germany, 91054
Prof. Dr. med. Stephan Klebe
Freiburg, Germany, 79106
Universitat zu Lubeck
Lubeck, Germany, 23562
Philipps Universitat Marburg
Marburg, Germany, 35043
George Huntington Institut
Münster, Germany, 48149
Kbo-Isar-Amper-Klinikum gGmbH
Taufkirchen, Germany, 84416
Universitätsklinikum Ulm
Ulm, Germany, 89081
Universitatsklinikum Wuerzburg
Wuerzburg, Germany, 97080
Poland
Copernicus Podmiot Leczniczy sp. z o.o.
Gdansk, Poland, 80462
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Poland, 31505
Solumed Centrum Medyczne
Poznan, Poland, 60529
Instytut Psychiatrii i Neurologii
Warszawa, Poland, 02957
United Kingdom
NHS Grampian Clinical Genetics Centre
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZA
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Walkergate Park Hospital
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE6 4QD
Birmingham & Solihull Mental Health NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2FG
John Van Geest Centre for Brain Repair
Cambridge, United Kingdom, CB2 0PY
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G51 4TF
Guys and St Thomas's NHS Foundation Trust
London, United Kingdom, SE1 9RT
University College London Hospitals Huntington's Disease Research Centre
London, United Kingdom, WC1B 5EH
University College London Hospitals NHS Foundation Trust
London, United Kingdom, WC1N 3BG
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
The National Institute for Health Research/Wellcome Trust Clinical Research Facility
Manchester, United Kingdom, M13 9WL

We're sorry

This trial is not recruiting at this time.
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