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



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 66
Updated:4/25/2018
Start Date:February 25, 2015
End Date:February 6, 2017

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An Open Label Extension Study To Investigate The Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Previously Completed Study A8241021

This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following
study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and
tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from
baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC)
assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of
treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of
treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding
A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will
be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15
mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260
subjects may take part in this open label extension


Inclusion Criteria:

- Subjects must have completed study A8241021

- Diagnosis of HD, including ≥36 CAG repeats.

Exclusion Criteria:

- Significant neurological disorder other than Huntington's disease.

- 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.
We found this trial at
18
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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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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Birmingham, Alabama 35233
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Englewood, Colorado 80113
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Indianapolis, Indiana 46202
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Los Angeles, California 90095
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Los Angeles, California 90095
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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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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Winston-Salem, North Carolina 27157
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