NISCI

Antibodies Against Nogo-A to Enhance Plasticity, Regeneration and Functional Recovery After Spinal Cord Injury - A Multicenter International Randomized Double Blind Placebo Controlled Phase II Clinical Proof of Concept Trial

15.05.2019 bis 31.12.2023

NISCI (Nogo-A Inhibition in acute Spinal Cord Injury) is a multicenter, multinational, placebo controlled phase-II study for the safety and preliminary efficacy of intrathecal anti-Nogo-A [NG101] in patients with acute cervical spinal cord injury. The purpose of the NISCI trial is to test if an antibody therapy can improve motor function and quality of life of tetraplegic patients. A previous trial showed this treatment is safe and well accepted. The study has 3 phases: screening/baseline phase, treatment phase, and a follow-up phase.
The study design will allow simultaneous enrolment of patients with complete or incomplete SCI. Enrolment and stratification of the patients is based and individualized prediction of upper limb outcomes.
This current trial has been approved by the National Ethics Committee and Ministry of Health for all participating trial sites.
For further information please visit NISCI website: https://nisci-2020.eu