Intermediate-Sized Expanded Access Study

NO_LONGER_AVAILABLE

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT05597436

Run by

Seelos Therapeutics, Inc.

Last updated by the study team

2025-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• University of California, Irvine — Orange, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Holy Cross Hospital - Phil Smith Neuroscience Institute — Fort Lauderdale, Florida, United States
• Nova Southeastern University — Fort Lauderdale, Florida, United States
• Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Sean M. Healey & AMG Center for ALS Neurological Clinical Research Institute, Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Spectrum Health/Corewell Health — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Texas Neurology, P.A.-Neal Site:769 — Dallas, Texas, United States
• Virginia Commonwealth University Clinical Research Unit — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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