Comparison · NCT05136885-e6396d97
SLS-005 vs Matching Placebo: Number of Participants That Experienced Death or Death Equivalent
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. SLS-005 vs Matching Placebo: Number of Participants That Experienced Death or Death Equivalent. Trial comparisons, record NCT05136885-e6396d97. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05136885-e6396d97
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0833 | 0.0459 | 0.147 | wilson | |
| Risk in group 2 | 0.0493 | 0.027 | 0.0883 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0341 | -0.02 | 0.101 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.69 | 0.725 | 3.95 | log | |
| Odds ratio, group 1 over group 2 | 1.75 | 0.708 | 4.35 | log | |
| Number needed to treat, for one more participant with the outcome on SLS-005 than on Matching Placebo | 29.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SLS-005 | SLS-005 is administered via infusion once weekly for 24 weeks.~SLS-005: Administration: Infusion Dose: 0.75 g/kg weekly | 10 | 120 | OG000 |
| Group 2 | Matching Placebo | Matching placebo is administered via infusion once weekly for 24 weeks.~Matching Placebo: Administration: Infusion Dose: equivalent weight-based volume as described for trehalose | 10 | 203 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants That Experienced Death or Death Equivalent
- Description
The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24 visit window (generally 175 days after baseline). The death equivalent criterion is the use of permanent assisted ventilation (PAV) for more than 22 hours per day for more than 7 days in a row.
- Time frame
- Baseline to 24 Weeks
- Population
Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510), Regimen C (NCT04414345) and Regimen D (NCT04615923) contributed placebo participants into the shared placebo cohort used for analysis.
Source ClinicalTrials.gov
Trial
- Title
- HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
- NCT number
- NCT05136885
- Phases
- PHASE2, PHASE3
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- SLS-005, Matching Placebo
- Lead sponsor
- Merit E. Cudkowicz, MD
- Results first posted
- 2024-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05136885?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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