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SLS-005-302: A Double-Blind, Randomized, Placebo-Controlled Trial to Assess Safety and Efficacy of SLS-005 (Trehalose Injection, 90.5 mg/mL for Intravenous Infusion) for the Treatment of Adults with Spinocerebellar Ataxia.
You are being invited to take part in the STRIDES study, a clinical research study of an investigational new drug (not approved as a marketed product) to treat Spinocerebellar Ataxia (SCA). This study is being sponsored by Seelos Therapeutics Inc. and the name of this investigational new drug is SLS-005
(trehalose). The study drug is a naturally occurring sugar which is used in small amounts in food products, cosmetics, and other drugs. Research studies of the study drug in cells, animals, and humans with SCA and other conditions, show that higher doses may help to clear out damaging molecules in cells in diseases such as SCA. The study drug is administered once a week for 52 consecutive weeks by an intravenous (IV) infusion to make sure enough trehalose reaches the cells of the brain and spinal cord.
STRIDES is a phase 2b/3 study planning to enroll up to 245 participants between the ages of 18 and 75 with SCA type-3. Participants will be recruited from up to 30 centers globally, approximately 7 centers will be in the United States. 200 patients will be assigned study drug (SLS-005) at a dose of 0.75 g/kg or placebo (a study drug look-alike, but it contains no active ingredients). An additional 45 patients will be assigned study drug (SLS-005) at a dose of 0.5 g/kg or placebo. Study participation will span 56 weeks; 2 weeks study screening to determine your eligibility for the study, 52 weeks of treatment with the study drug, and ending with a safety follow-up visit 2 weeks after the last study drug administration. You may be reimbursed for reasonable expenses such as mileage and parking for travel associated with each study visit.
To qualify for the trial, you must be a man or woman between 18 and 75 years old with a clinical diagnosis of SCA 3 with genetic confirmation, a body mass index between 18 kg/m2 and 35 kg/m2 , and you cannot be pregnant or breastfeeding. Patients who have received prior treatment with SLS-005, any other IV formulation, or with a known hypersensitivity to trehalose will not be eligible for the study. Additionally, patients with any of the following conditions will not be eligible for participation:
- Current diagnosis and/or healthcare professional recommended treatment (medication and/or diet) of diabetes mellitus type 1 or type 2.
- Chronic liver disease including hepatitis B; Hepatitis C unless successful curative treatment is documented; human immunodeficiency virus (HIV) infection.
- Prior history of liver induced injury.
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