Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

ALS patients get expanded access to experimental Sugar-Based drug

NCT ID NCT05597436

Disease control Sponsor: Seelos Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This program gives ALS patients who cannot join other clinical trials access to an experimental drug called trehalose (SLS-005). Trehalose is a sugar solution given once a week through a vein. The goal is to see if it can help control the disease. The program is no longer available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trehalose (SLS-005)
What this could lead to
If this works, it could slow progression of ALS and improve quality of life for patients who cannot join other trials.
What could go wrong
This is an expanded access program, not a formal trial, so evidence is limited. Trehalose is still investigational and may not slow the disease or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Sporadic or familial ALS. 2. Age 18 years or older. 3. Cohort 1: Patients who do not qualify for any reasonably accessible ongoing clinical trial. 4. 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. 5. Capable of providing informed consent and complying with study procedures, in the Site Investigator's (SI's) opinion. 6. 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. 7. Participants must have a life expectancy of at least 6 months in SI's opinion. Exclusion Criteria: 1. Current diagnosis or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus. 2. Screening glucose \>=140 mg/dl. 3. Known hypersensitivity to trehalose. 4. Current use of oral trehalose. 5. Inability for participant to return to site for weekly drug administration, until approved for home infusions. 6. Screening body weight \>144 kilograms. 7. 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. 8. Females who are pregnant or nursing or who plan to get pregnant during the course of the EAP. 9. Females of child-bearing potential, or males, who are unwilling or unable to use highly effective methods of birth control. 10. 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. 11. 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. 12. 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. 13. 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. 14. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Amyotrophic lateral sclerosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, 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

  • Hospital for Special Care

    New Britain, Connecticut, 06053, United States

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105, United States

  • Nova Southeastern University

    Fort Lauderdale, Florida, 33328, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706, United States

  • Sean M. Healey & AMG Center for ALS Neurological Clinical Research Institute, Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Spectrum Health/Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Texas Neurology, P.A.-Neal Site:769

    Dallas, Texas, 75206, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, 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

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Virginia Commonwealth University Clinical Research Unit

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.