The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.
This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
Time frame: Screening, Day 0, Weeks 9, 12
Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
Time frame: 12 weeks
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.
Time frame: 12 weeks
Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 12 weeks
Change in Berg Balance Test (BBT)
The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.
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Teva Investigational Site 057
Birmingham, Alabama, United States
Teva Investigational Site 038
Phoenix, Arizona, United States
Teva Investigational Site 298
Fayetteville, Arkansas, United States
Teva Investigational Site 050
Los Angeles, California, United States
Teva Investigational Site 052
Englewood, Colorado, United States
Teva Investigational Site 333
Washington D.C., District of Columbia, United States
Teva Investigational Site 196
Boca Raton, Florida, United States
Teva Investigational Site 160
Gainesville, Florida, United States
Teva Investigational Site 014
Miami, Florida, United States
Teva Investigational Site 032
Atlanta, Georgia, United States
...and 33 more locations
Time frame: Baseline, 12 weeks