Trials / No Longer Available
No Longer AvailableNCT05597436
Intermediate-Sized Expanded Access Study
An Expanded Access Protocol of Intravenous Trehalose Injection 90.5 mg/mL Treatment of Patients With Amyotrophic Lateral Sclerosis
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Seelos Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trehalose | Once weekly 0.75g/kg administration |
Timeline
- First posted
- 2022-10-28
- Last updated
- 2025-09-02
Locations
21 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05597436. Inclusion in this directory is not an endorsement.