The purpose of the NISCI trial is to test if an antibody therapy can improve movement and
quality of life of tetraplegic patients. A previous trial showed this treatment is safe and
well accepted. This is a placebo controlled, randomized, double blind, multicenter,
multinational study to assess the safety, tolerability, feasibility and preliminary efficacy
of early (within 4-28 days post injury) initiation of treatment with repeated bolus
injections of NG-101 in cervical acute SCI patients. 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.
For further information please visit NISCI website: https://nisci-2020.eu
Phase:
Phase 2
Details
Lead Sponsor:
University of Zurich
Collaborators:
EMSCI.org Foundation Wings For Life Heidelberg University Hospital Spinal Cord Injury Center Horizon 2020 - European Commission KKS Netzwerk State Secretariat for Education Research and Innovation, Switzerland Swiss Paraplegic Research