NCT03935321

NISCI - Nogo Inhibition in Spinal Cord Injury

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Spinal Cord Injury, Acute

Interventions

Type	Name	Description
DRUG	NG-101	6 intrathecal bolus injections, each of 45mg
DRUG	Placebos	6 intrathecal bolus injections, each of 45mg

Timeline

• Start date: 2019-05-15
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2019-05-02
• Last updated: 2023-04-04

Locations

13 sites across 4 countries: Czechia, Germany, Spain, Switzerland