NCT05490563

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Seelos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 2b/3 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).

Detailed description

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.

Conditions

• Spinocerebellar Ataxia Type 3

Interventions

Type	Name	Description
DRUG	SLS-005	SLS-005
DRUG	Placebo	Placebo (sodium chloride injection, 0.9%, USP)

Timeline

• Start date: 2022-06-03
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2022-08-05
• Last updated: 2024-04-24

Locations

23 sites across 8 countries: United States, Australia, Brazil, Germany, Portugal, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study