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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 65
Updated:10/18/2017
Start Date:September 2014
End Date:October 2016

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A Phase 2, Randomized, Placebo Controlled, Double Blind Proof-of-concept Study Of The Efficacy And Safety Of Pf-02545920 In Subjects With Huntington's Disease

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.


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;
We found this trial at
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Charlestown, Massachusetts 02129
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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1876 5th Avenue South
Birmingham, Alabama 35233
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43210
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Englewood, Colorado 80113
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Indianapolis, Indiana 46202
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Irvine, California 92697
949-824-5011
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Los Angeles, California 90095
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Phoenix, Arizona 85054
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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St. Louis, Missouri 63108
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Winston-Salem, North Carolina 27157
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