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 |
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
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
sites
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Vancouver, British Columbia V6T 1W5
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