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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
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501004-10-00
Acronym
SLS-005-302
Enrollment
58
Registered
2022-12-13
Start date
2023-01-30
Completion date
2024-02-12
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxia type-3 (SCA3)

Brief summary

Change from baseline in m-SARA total score at Week 52 in participants with SCA3 treated with SLS-005 0.75 g/kg compared to placebo

Detailed description

Key Secondary Endpoints In participants treated with SLS-005 0.75 g/kg: • Change from baseline in Clinical Global Impression of Severity (CGI-S) at Week 52, • Change from baseline in Patient Global Impression of Severity (PGI-S) at Week 52, • Change from baseline in Friedreich’s Ataxia Rating Scale – Activities of Daily Living (FARS-ADL) score at Week 52, • Change from baseline in m-SARA total score at Week 26, Secondary Endpoints In participants with treated with SLS-005 0.75 g/kg: • Changes from baseline in m-SARA total score at Weeks 4, 13, and 39, • Changes from baseline in CGI-S at Weeks 4, 13, 26, and 39, • Changes from baseline in PGI-S at Weeks 4, 13, 26, and 39, • Changes from baseline in FARS-ADL score at Weeks 4, 13, 26, and 39, • Changes from baseline in scores for each item of the m-SARA at Weeks 4, 13, 26, 39, and 52, In all participants: • Incidences of treatment-emergent adverse events (TEAEs) and SAEs, including clinically significant laboratory and ECG abnormalities

Interventions

DRUGTrehalose Injection Placebo
DRUG9%
DRUGSLS-005 Placebo
DRUGSUB39441

Sponsors

Seelos Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in m-SARA total score at Week 52 in participants with SCA3 treated with SLS-005 0.75 g/kg compared to placebo

Secondary

MeasureTime frame
Key Secondary Endpoints In participants treated with SLS-005 0.75 g/kg: • Change from baseline in Clinical Global Impression of Severity (CGI-S) at Week 52, • Change from baseline in Patient Global Impression of Severity (PGI-S) at Week 52, • Change from baseline in Friedreich’s Ataxia Rating Scale – Activities of Daily Living (FARS-ADL) score at Week 52, • Change from baseline in m-SARA total score at Week 26, Secondary Endpoints In participants with treated with SLS-005 0.75 g/kg: • Changes from baseline in m-SARA total score at Weeks 4, 13, and 39, • Changes from baseline in CGI-S at Weeks 4, 13, 26, and 39, • Changes from baseline in PGI-S at Weeks 4, 13, 26, and 39, • Changes from baseline in FARS-ADL score at Weeks 4, 13, 26, and 39, • Changes from baseline in scores for each item of the m-SARA at Weeks 4, 13, 26, 39, and 52, In all participants: • Incidences of treatment-emergent adverse events (TEAEs) and SAEs, including clinically significant laboratory and ECG abnormalities

Countries

Germany, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026