STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia

This is a randomized, double‐blind, placebo‐controlled trial to assess the safety and efficacy of SLS‐005 for the treatment of adults with SCA. The study consists of a 2‐week screening period, a 52‐week treatment period, and a 2‐week safety follow‐up period. Eligible participants between the ages of 18‐75 years, will be randomized to treatment with SLS‐005 or equivalent placebo (sodium chloride injection, 0.9%, USP). The study plans to enroll up to 245 participants with SCA3. Biomarkers associated with neuro‐axonal injury, pharmacokinetics, Modified Scale for Assessment and Rating of Ataxia (m‐SARA), Clinical Global Impression of Severity (CGI‐S), Patient Global Impression of Severity (PGI‐S), and Friedreich's Ataxia Rating Scale ‐ Activities of Daily Living (FARS‐ADL), will be assessed at screening and/or baseline and at scheduled times throughout the study.