Trial · NCT05136885

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

NCT05136885, Phase 2, Phase 3, Completed, Merit E. Cudkowicz, MD; results first posted 2024-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose. Trials, record NCT05136885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05136885

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
NCT number: NCT05136885
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 161 participants, actual
Lead sponsor: Merit E. Cudkowicz, MD
Conditions: Amyotrophic Lateral Sclerosis
Interventions: SLS-005, Matching Placebo
First posted: 2021-11-29
Last updated: 2025-05-14
Results first posted: 2024-08-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Progression as Assessed by the ALSFRS-R Slope	24 Weeks	Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Primary	Mortality Event Rate	Baseline to 24 Weeks	Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times.
Secondary	Respiratory Function	Baseline to 24 Weeks	Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Secondary	Muscle Strength	Baseline to 24 Weeks	Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD).
Secondary	Number of Participants That Experienced Death or Death Equivalent	Baseline to 24 Weeks	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Progression as Assessed by the ALSFRS-R Slope	24 Weeks	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.	points per month	MEAN
PRIMARY	Mortality Event Rate	Baseline to 24 Weeks	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.	events per month	MEAN
SECONDARY	Respiratory Function	Baseline to 24 Weeks	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.One SLS-005 participant and 4 placebo participants from FAS were not analyzed due to missing data.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Muscle Strength	Baseline to 24 Weeks	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. Two placebo participants from FAS were not analyzed due to missing data.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants That Experienced Death or Death Equivalent	Baseline to 24 Weeks	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.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease Progression as Assessed by the ALSFRS-R Slope	SLS-005	-0.91	Standard Deviation 0.090	points per month
Disease Progression as Assessed by the ALSFRS-R Slope	Matching Placebo	-1.06	Standard Deviation 0.091	points per month
Mortality Event Rate	SLS-005	0.010	Standard Deviation 0.0025	events per month
Mortality Event Rate	Matching Placebo	0.012	Standard Deviation 0.0027	events per month
Respiratory Function	SLS-005	-11.40	Standard Error 1.431	percent change
Respiratory Function	Matching Placebo	-10.85	Standard Error 1.089	percent change
Muscle Strength	SLS-005	-26.19	Standard Error 2.568	percent change
Muscle Strength	Matching Placebo	-27.11	Standard Error 1.876	percent change
Number of Participants That Experienced Death or Death Equivalent	SLS-005	10		Participants
Number of Participants That Experienced Death or Death Equivalent	Matching Placebo	10		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SLS-005	120
Overall Study	STARTED	Matching Placebo	41
Overall Study	COMPLETED	SLS-005	92
Overall Study	COMPLETED	Matching Placebo	37
Overall Study	NOT COMPLETED	SLS-005	28
Overall Study	NOT COMPLETED	Matching Placebo	4

Source ClinicalTrials.gov

Adverse events74

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Muscular weakness	Nervous system disorders	SLS-005	22	120	30
other	Muscular weakness	Nervous system disorders	Matching Placebo	8	41	14
other	Neuromyopathy	Nervous system disorders	SLS-005	18	120	22
other	Neuromyopathy	Nervous system disorders	Matching Placebo	4	41	5
other	Headache	Nervous system disorders	SLS-005	11	120	15
other	Headache	Nervous system disorders	Matching Placebo	0	41	0
other	Dysarthria	Nervous system disorders	SLS-005	4	120	4
other	Dysarthria	Nervous system disorders	Matching Placebo	4	41	4
other	Fall	Injury, poisoning and procedural complications	SLS-005	32	120	63
other	Fall	Injury, poisoning and procedural complications	Matching Placebo	8	41	17

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SLS-005	6	120
Total, all-cause mortality	Matching Placebo	0	41
Total, other adverse events	SLS-005	107	120
Total, other adverse events	Matching Placebo	33	41
Total, serious adverse events	SLS-005	19	120
Total, serious adverse events	Matching Placebo	3	41

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40409314	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SLS-005 vs Matching Placebo: deaths from any cause	Trial comparisons
SLS-005 vs Matching Placebo: Number of Participants That Experienced Death or Death Equivalent	Trial comparisons
SLS-005 vs Matching Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05136885

GET https://conductscience.org/api/trials/v1/NCT05136885/events?page=2

API reference For AI assistants