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

2019P003518E

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.

2022-02-21

2023-08-25

2023-08-25

Completed

Early phase I

161

Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Current diagnosis or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus 2. Master Protocol screening glucose \>140 mg/dl 3. Prior treatment with IV trehalose or known hypersensitivity to trehalose 4. Current use of oral trehalose (see prohibited medication Section 5.9) 5. Inability for participant to return to site for weekly drug administration, until approved for home infusions

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 161, 'type': 'ACTUAL'}}

2023-10-04