NCT06973629Phase 3Not yet recruiting

Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)

Study sponsor: Brainstorm-Cell Therapeutics

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-11-01Estimated

Enrollment · participants200Estimated

Source updated2025-05-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Amyotrophic Lateral Sclerosis (ALS); Amyotrophic Lateral Sclerosis

Treatments or interventions studied

Debamestrocel - MSC-NTF (NurOwn)BiologicalAlso known as NurOwn
PlaceboBiological

Primary outcomes · main study measures

Read the study measures

measure: Change in the ALSFRS-R total score from baseline to Week 24; description: To evaluate the efficacy of NurOwn compared to placebo in the treatment of participants with ALS based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) which is a 12-item clinician-administered questionnaire. Each item is scored between 0 and 4, with the total ALSFRS-R score between 0 and 48 where a higher score reflects a better outcome.; timeFrame: From baseline to Week 24; measure: 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; description: To evaluate the safety and tolerability of NurOwn in the treatment of participants with ALS throughout the study including the DBPC period (Part A) to Week 24 and the Open Label Extension (Part B).; timeFrame: From baseline to Week 48

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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