NO_LONGER_AVAILABLENot Applicable

Intermediate-Sized Expanded Access Study

United States

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

Trial details

NCT IDNCT05597436

SponsorSeelos Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials