The study examines Huntington’s Disease, a rare inherited brain disorder that causes movement problems, thinking difficulties, and changes in behavior. The investigational drug being tested is SKY-0515, an oral tablet given in different strengths. Some participants will receive the active drug while others will receive a matching placebo. The purpose of the study is to see if SKY-0515 can improve the signs and symptoms of Huntington’s Disease.
Participants will take the assigned tablets each day for about a year and will attend regular visits where doctors will check safety, record any side effects, and measure changes in disease features. The main way the study looks at benefit is the change from the start to week 72 in the cUHDRS, a score that combines movement, thinking, and daily function into one number. Additional information will be gathered from separate scores such as the Total motor score (which rates movement problems), the Total functional capacity (which looks at ability to do everyday tasks), the Independence scale (which measures how much help a person needs), the Stroop Color and Word test (which checks attention and mental flexibility), and the Symbol digit modalities test (which evaluates processing speed).
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