Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
← catalyst calendarNCT06973629 · readout in 805 d
Sponsored by Brainstorm-Cell Therapeutics (industry) · BCLI — their whole pipeline →.
Phase
Phase 3
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
200estimated
Sites
15
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-30 | estimated | When the study began enrolling |
| Primary completion | 2028-11-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-05-01 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Amyotrophic Lateral Sclerosis
Interventions
- Biological: Debamestrocel - MSC-NTF (NurOwn) — also filed as NurOwn
- Biological: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange in the ALSFRS-R total score from baseline to Week 24
measured From baseline to Week 24
Frequency and severity of adverse events including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), death, abnormalities in laboratory evaluations, physical examinations, vital signs and electrocardiogram (ECG) assessments
measured From baseline to Week 48
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