HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
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|ClinicalTrials.gov Identifier: NCT05136885|
Recruitment Status : Enrolling by invitation
First Posted : November 29, 2021
Last Update Posted : March 23, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: SLS-005 Drug: Matching Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose|
|Actual Study Start Date :||February 21, 2022|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||October 2023|
SLS-005 is administered via infusion once weekly for 24 weeks.
Administration: Infusion Dose: 0.75 g/kg weekly
Placebo Comparator: Matching Placebo
Matching placebo is administered via infusion once weekly for 24 weeks.
Drug: Matching Placebo
Administration: Infusion Dose: equivalent weight-based volume as described for trehalose
- Disease Progression [ Time Frame: 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.
- Respiratory Function [ Time Frame: 24 Weeks ]Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
- Muscle Strength [ Time Frame: 24 Weeks ]Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD).
- Survival [ Time Frame: 24 Weeks ]Comparison of rate of occurrence between groups.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136885
|United States, Massachusetts|
|Healey Center for ALS at Mass General|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Merit Cudkowicz, MD||Massachusetts General Hospital|
|Responsible Party:||Merit E. Cudkowicz, MD, Chief, Neurology Department, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||November 29, 2021 Key Record Dates|
|Last Update Posted:||March 23, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Regimen Specific Appendix
Lou Gehrig's Disease
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases