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

Phase 2 & 3
Waitlist Available
Led By Merit Cudkowicz, MD
Research Sponsored by Merit E. Cudkowicz, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial tests a sugar solution called Trehalose to help people with ALS. The goal is to see if it can protect nerve cells and improve their survival. Trehalose has been shown to delay the progression of amyotrophic lateral sclerosis (ALS).

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)
  • Amyotrophic Lateral Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Progression as Assessed by the ALSFRS-R Slope
Mortality Event Rate
Secondary study objectives
Muscle Strength
Number of Participants That Expirenced Death or Death Equivalent
Respiratory Function

Side effects data

From 2023 Phase 2 & 3 trial • 161 Patients • NCT05136885
27%
Fall
18%
Muscular weakness
16%
Fatigue
15%
Neuromyopathy
13%
Constipation
11%
Diarrhoea
10%
COVID-19
9%
Headache
8%
Dysphagia
7%
Cough
7%
Post lumbar puncture syndrome
7%
Musculoskeletal pain
6%
Urinary tract infection
6%
Infusion site bruising
5%
Infusion related reaction
5%
Abdominal discomfort
5%
Dyspnoea
5%
Oedema peripheral
3%
Salivary hypersecretion
3%
Dysarthria
3%
Amyotrophic lateral sclerosis
3%
Acute respiratory failure
2%
Pneumonia
2%
Respiratory failure
1%
Pneumonia aspiration
1%
Complication associated with device
1%
Abdominal pain upper
1%
Urticaria
1%
Hypertension
1%
Syncope
1%
Cerebrovascular accident
1%
Hip fracture
1%
Pulmonary embolism
1%
Breast cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Matching Placebo
SLS-005

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SLS-005Experimental Treatment1 Intervention
SLS-005 is administered via infusion once weekly for 24 weeks.
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo is administered via infusion once weekly for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLS-005
2022
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

Seelos Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
269 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
Merit E. Cudkowicz, MDLead Sponsor
7 Previous Clinical Trials
2,693 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
2,693 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit Cudkowicz, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
2,510 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,510 Patients Enrolled for Amyotrophic Lateral Sclerosis
~43 spots leftby Dec 2025
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