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| ID | Type | Description | Link |
|---|---|---|---|
| UF1NS131791 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| National Institutes of Health (NIH) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trehalose | Drug | Once weekly 0.75g/kg administration |
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| University of California, Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40857020 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2024 | Aug 12, 2025 |
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| 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2025 | Aug 12, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014199 | Trehalose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |
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