Amyotrophic Lateral SclerosisNCT05597436
Intermediate-Sized Expanded Access Study
A study testing Trehalose in people with Amyotrophic Lateral Sclerosis, run by Seelos Therapeutics, Inc. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Trehalose
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 21 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
University of Colorado
Aurora, Colorado, 80045
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
Sean M. Healey & AMG Center for ALS Neurological Clinical Research Institute, Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Texas Neurology, P.A.-Neal Site:769
Dallas, Texas, 75206
Holy Cross Hospital - Phil Smith Neuroscience Institute
Fort Lauderdale, Florida, 33308
Nova Southeastern University
Fort Lauderdale, Florida, 33328
Spectrum Health/Corewell Health
Grand Rapids, Michigan, 49503
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Minnesota
Minneapolis, Minnesota, 55455
Hospital for Special Care
New Britain, Connecticut, 06053
University of California, Irvine
Orange, California, 92697
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Virginia Commonwealth University Clinical Research Unit
Richmond, Virginia, 23298
University of California, San Francisco
San Francisco, California, 94115
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: An Expanded Access Protocol of Intravenous Trehalose Injection 90.5 mg/mL Treatment of Patients With Amyotrophic Lateral Sclerosis
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.
Read the detailed description
Approximately 70 participants receive a weekly infusion of SLS-005 for up to 24 weeks. There are 25 infusions over 24 weeks (first infusion occurs at the Screening/Baseline Visit). In addition to infusion visits, participants will have three scheduled in-clinic visits at Screening/Baseline, Week 3, and Week 24, and 2 phone call or telemedicine visits at Week 12 and approximately 28 days following the last dose of the investigational medical product.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Trehalose
- Keywords
- ALS, Lou Gehrig's Disease, Trehalose, Seelos Therapeutics, SLS-005
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrehaloseDrug
Also called SLS-005 Intravenous Trehalose Injection 90.5 mg/mL
Once weekly 0.75g/kg administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Seelos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Suma Babu, MD,MPH,MBBS, Principal investigator, Massachusetts General HospitalJames D Berry, MD,MPH, Principal investigator, Massachusetts General HospitalSabrina Paganoni, MD,PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597436
- Sponsor's protocol ID
- SLS-005-EAP
- Other IDs
- UF1NS131791
- Status last verified
- Aug 2025
- First submitted
- 24 Oct 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
Publications
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.
PubMed 40857020
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Protocol of Intravenous Trehalose Injection 90.5 mg/mL Treatment of Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05597436
- Acronym / sponsor ID
- SLS-005-EAP
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS, Lou Gehrig's Disease, Trehalose, Seelos Therapeutics, SLS-005
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Seelos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 70 participants receive a weekly infusion of SLS-005 for up to 24 weeks. There are 25 infusions over 24 weeks (first infusion occurs at the Screening/Baseline Visit). In addition to infusion visits, participants will have three scheduled in-clinic visits at Screening/Baseline, Week 3, and Week 24, and 2 phone call or telemedicine visits at Week 12 and approximately 28 days following the last dose of the investigational medical product.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrehaloseAlso: SLS-005 Intravenous Trehalose Injection 90.5 mg/mLOnce weekly 0.75g/kg administration | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Results publication: PubMed 40857020Krivickas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suma Babu, MD,MPH,MBBS principal investigator
Massachusetts General Hospital
James D Berry, MD,MPH principal investigator
Massachusetts General Hospital
Sabrina Paganoni, MD,PhD principal investigator
Massachusetts General Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trehalose in people with Amyotrophic Lateral Sclerosis, run by Seelos Therapeutics, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.