BrainStorm is proceeding with a randomized, double-blind, placebo-controlled multi-dose Phase 3 trial that will be conducted at multiple sites.
Additional information on the NurOwn® clinical trial development program can be found Here .
Please see link to the Northeast ALS Consortium (NEALS) Webinar entitled NurOwn® Clinical Development Program.
For additional information on enrollment in the NurOwn® phase 3 trial contact one of the clinical trial sites for details and screening.
Information is posted on clinicaltrials.gov .
We have undertaken three clinical trials in ALS to date
- A single-arm, open label phase 1/2 study – completed.
- A single-arm, open label, dose-escalation phase 2a study – completed.
- A randomized, double-blind, placebo-controlled phase 2 study – completed.
In all three trials, the primary endpoints were the safety and tolerability of a single intramuscular, intrathecal or simultaneous intramuscular and intrathecal administration. Key secondary efficacy endpoints included the rate of change in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) and in forced vital capacity (FVC) during the post-treatment period compared to a three month pre-treatment run-in period.