Phase 3
N=161
HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05136885 ↗Enrolled (actual)
161
Serious AEs
13.7%
Results posted
Aug 2024
Primary outcome: Primary: Disease Progression as Assessed by the ALSFRS-R Slope — -0.91; -1.06 points per month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SLS-005 (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merit E. Cudkowicz, MD
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Assessed by the ALSFRS-R Slope |
-0.91; -1.06 | — |
| PRIMARY Mortality Event Rate |
0.010; 0.012 | — |
| SECONDARY Respiratory Function |
-11.40; -10.85 | 0.7607 |
| SECONDARY Muscle Strength |
-26.19; -27.11 | 0.7737 |
| SECONDARY Number of Participants That Experienced Death or Death Equivalent |
10; 10 | 0.2137 |
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.
Eligibility Criteria
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).
- 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
Data sourced from ClinicalTrials.gov (NCT05136885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.