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 |
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.
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
22
sites
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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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
Birmingham, Alabama 35233
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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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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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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