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HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose

NCT05136885 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2025-05-14

Study results available
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Summary

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen E will evaluate the safety and efficacy of a single study drug, SLS-005 (Trehalose injection, 90.5 mg/mL for intravenous infusion) in participants with ALS.

Conditions

Interventions

DRUG

SLS-005

Administration: Infusion Dose: 0.75 g/kg weekly

DRUG

Matching Placebo

Administration: Infusion Dose: equivalent weight-based volume as described for trehalose

Sponsors & Collaborators

  • Seelos Therapeutics, Inc.

    collaborator INDUSTRY

  • Merit E. Cudkowicz, MD

    lead OTHER

Principal Investigators

  • Merit Cudkowicz, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2023-08-25
Completion
2023-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136885 on ClinicalTrials.gov