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

PHASE2CompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

September 30, 2016

Study Completion Date

October 31, 2016

Conditions
Huntington's Disease
Interventions
DRUG

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.

DRUG

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.

OTHER

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.

Trial Locations (57)

10117

Charite - Universitatsmedizin Berlin, Berlin

12208

Albany Medical College, Albany

23562

Universitat zu Lubeck, Lübeck

27157

Wake Forest Baptist Medical Center - Dept. of Neurology, Winston-Salem

31505

Krakowska Akademia Neurologii Sp. z o.o., Krakow

32607

University of Florida Center for Movement Disorders and Neurorestoration, Gainesville

35043

Philipps Universitat Marburg, Marburg

35233

The Kirklin Clinic of UAB Hospital, Birmingham

The University of Alabama at Birmingham, Birmingham

University of Alabama at Birmingham, Birmingham

43210

Davis Medical Center, Columbus

43221

The Wexner Medical Center at the Ohio State University, Columbus

Wexner Medical Center at the Ohio State University, Columbus

44195

Cleveland Clinic Foundation Hospital Pharmacy, Cleveland

The Cleveland Clinic Foundation, Cleveland

44791

Prof. Dr. Carsten Saft, Bochum

46202

Indiana University Health Neuroscience Center, Indianapolis

48149

George Huntington Institut, Münster

52074

Uniklinik RWTH Aachen, Aachen

60529

Solumed Centrum Medyczne, Poznan

63110

Washington University School of Medicine, St Louis

77030

Baylor College of Medicine, Houston

79106

Prof. Dr. med. Stephan Klebe, Freiburg im Breisgau

80113

Rocky Mountain Movement Disorders Center, Englewood

80462

Copernicus Podmiot Leczniczy sp. z o.o., Gdansk

81675

Technische Universität München, München

84416

Kbo-Isar-Amper-Klinikum gGmbH, Taufkirchen

85054

Mayo Clinic Arizona, Phoenix

85259

Mayo Clinic Arizona, Scottsdale

89081

Universitätsklinikum Ulm, Ulm

90095

Ronald Regan UCLA Medical Center Drug Information Center, Los Angeles

UCLA Neurology Clinic, Los Angeles

UCLA Radiology, Los Angeles

91054

Friedrich-Alexander-Universität, Erlangen

92697

University of California, Irvine, Irvine

97080

Universitatsklinikum Wuerzburg, Würzburg

02129

Massachusetts General Hospital, Charlestown

V6T 2B5

The Centre for Huntington Disease, Vancouver

M3B 2S7

Centre for Movement Disorders, Toronto

H2L 4M1

CHUM-Notre-Dame Hospital, Montreal

H4L 4M1

CHUM Notre Dame, Pharmacie, Montreal

02957

Instytut Psychiatrii i Neurologii, Warsaw

AB25 2ZA

NHS Grampian, Clinical Genetics Centre, Aberdeen

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

OX3 9DU

Oxford University Hospitals NHS Trust, Oxford

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

B15 2FG

Birmingham & Solihull Mental Health NHS Foundation Trust, Birmingham

CB2 0PY

John Van Geest Centre for Brain Repair, Cambridge

CF14 4XW

University of Wales Hospital, Cardiff

G51 4TF

NHS Greater Glasgow and Clyde, Glasgow

SE1 9RT

Clinical Research Facility, London

WC1B 5EH

University College London Hospitals Huntington's Disease Research Centre, London

WC1N 3BG

University College London Hospitals NHS Foundation Trust, London

M13 9WL

Central Manchester University Hospitals NHS Foundation Trust, Manchester

The National Institute for Health Research/Wellcome Trust Clinical Research Facility, Manchester

NE3 3XT

St Nicholas Hospital, Newcastle upon Tyne

NE4 5PL

Newcastle Magnetic Resonance Centre, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02197130 - Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease | Biotech Hunter | Biotech Hunter