Intermediate-Sized Expanded Access Study
An Expanded Access Protocol of Intravenous Trehalose Injection 90.5 mg/mL Treatment of Patients With Amyotrophic Lateral Sclerosis
2 other identifiers
expanded_access
N/A
1 country
21
Brief Summary
This expanded access protocol is to provide access to the investigational product, SLS-005, to participants with ALS who are not eligible to participate in clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 28, 2022
CompletedSeptember 2, 2025
August 1, 2025
October 24, 2022
August 29, 2025
Conditions
Keywords
Interventions
Once weekly 0.75g/kg administration
Eligibility Criteria
You may qualify if:
- Sporadic or familial ALS.
- Age 18 years or older.
- Cohort 1: Patients who do not qualify for any reasonably accessible ongoing clinical trial.
- Cohort 2: Patients who have completed the open label extension (OLE) period of Regimen E of the HEALEY ALS Platform Trial and are not eligible for enrollment in another treatment regimen of the platform study.
- Capable of providing informed consent and complying with study procedures, in the Site Investigator's (SI's) opinion.
- Participants have established care with a physician at the specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP.
- Participants must have a life expectancy of at least 6 months in SI's opinion.
You may not qualify if:
- Current diagnosis or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus.
- Screening glucose \>=140 mg/dl.
- Known hypersensitivity to trehalose.
- Current use of oral trehalose.
- Inability for participant to return to site for weekly drug administration, until approved for home infusions.
- Screening body weight \>144 kilograms.
- Participant with a history of any clinically significant or unstable medical condition or lab abnormality based on the SI's judgment that may interfere with assessment of the study objectives, with safety or full participation.
- Females who are pregnant or nursing or who plan to get pregnant during the course of the EAP.
- Females of child-bearing potential, or males, who are unwilling or unable to use highly effective methods of birth control.
- Use of investigational treatments for ALS (as part of participation in a clinical trial or another EAP) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Screening Visit.
- Permanent assisted ventilation (PAV), defined as more than 22 hours per day of noninvasive or invasive mechanical ventilation for more than seven consecutive days. The date of onset of PAV is the first day of the seven days.
- Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
- Presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.
- Patients who chose to take experimental medications and/or supplements, and that is the only reason they are not eligible for trials, won't be eligible for the EAP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seelos Therapeutics, Inc.lead
- Massachusetts General Hospitalcollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (21)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
University of California, Irvine
Orange, California, 92697, United States
University of California, San Francisco
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
Hospital for Special Care
New Britain, Connecticut, 06053, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Holy Cross Hospital - Phil Smith Neuroscience Institute
Fort Lauderdale, Florida, 33308, United States
Nova Southeastern University
Fort Lauderdale, Florida, 33328, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Sean M. Healey & AMG Center for ALS Neurological Clinical Research Institute, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Spectrum Health/Corewell Health
Grand Rapids, Michigan, 49503, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Texas Neurology, P.A.-Neal Site:769
Dallas, Texas, 75206, United States
Virginia Commonwealth University Clinical Research Unit
Richmond, Virginia, 23298, United States
Related Publications (1)
Krivickas B, Scirocco E, Giacomelli E, Sharma S, Benson M, Keegan M, Kulesa-Kelley J, Chibnik LB, Casagrande G, Heyd L, Chase M, Drake K, Mohapatra S, Hagar JL, Hasenoehrl MG, Dagostino D, Sherman AV, Leite A, Yu H, Rosenthal J, Miller T, McCaffrey A, Gwathmey K, Locatelli E, Bayat E, Heitzman D, Young E, Goyal NA, Whitesell J, Felice K, Ilieva H, Swenson A, Walk D, Alameda G, Foster L, McIlduff CE, Walsh A, Zilliox L, Ajroud-Driss S, Bodkin C, Katz J, Ladha S, Rivner M, Rosow L, Twydell P, Wasiewski W, Babu S, Berry JD, Paganoni S. Multicenter Expanded Access Protocol for Research Through Access to Trehalose in People With Amyotrophic Lateral Sclerosis. Muscle Nerve. 2025 Nov;72(5):1108-1116. doi: 10.1002/mus.70011. Epub 2025 Aug 26.
PMID: 40857020RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suma Babu, MD,MPH,MBBS
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
James D Berry, MD,MPH
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Sabrina Paganoni, MD,PhD
Massachusetts General Hospital
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
October 28, 2022
Last Updated
September 2, 2025
Record last verified: 2025-08