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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136885
• Other study ID #: 2019P003518E
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 21, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen E SLS-005 - Trehalose, the participant will complete a screening visit to assess additional Regimen E eligibility criteria. Once Regimen E eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active SLS-005 or matching placebo.

Regimen E will enroll by invitation, as participants may not choose to enroll in Regimen E. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen E.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Drug:
• SLS-005
Administration: Infusion Dose: 0.75 g/kg weekly
• Matching Placebo
Administration: Infusion Dose: equivalent weight-based volume as described for trehalose

Locations

Country	Name	City	State
United States	Healey Center for ALS at Mass General	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Merit E. Cudkowicz, MD	Seelos Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression	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.	24 Weeks
Secondary	Respiratory Function	Change in respiratory function over time as measured by Slow Vital Capacity (SVC).	24 Weeks
Secondary	Muscle Strength	Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD).	24 Weeks
Secondary	Survival	Comparison of rate of occurrence between groups.	24 Weeks