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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT05136885

Run by

Merit E. Cudkowicz, MD

People needed

161

Starts

2022-02-21

Expected to finish

2023-08-25

Last updated by the study team

2025-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

You may not qualify if…

• The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
• Current diagnosis or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus
• Master Protocol screening glucose >140 mg/dl
• Prior treatment with IV trehalose or known hypersensitivity to trehalose
• Current use of oral trehalose (see prohibited medication Section 5.9)
• Inability for participant to return to site for weekly drug administration, until approved for home infusions

Where it is running

• Healey Center for ALS at Mass General — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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