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NISCI - Nogo Inhibition in Spinal Cord Injury

NCT03935321 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-04-04

No results posted yet for this study

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

DRUG

NG-101

6 intrathecal bolus injections, each of 45mg

DRUG

Placebos

6 intrathecal bolus injections, each of 45mg

Sponsors & Collaborators

  • EMSCI.org

    collaborator UNKNOWN

  • State Secretariat for Education Research and Innovation, Switzerland

    collaborator OTHER

  • Horizon 2020 - European Commission

    collaborator OTHER

  • Foundation Wings For Life

    collaborator OTHER

  • Swiss Paraplegic Research, Nottwil

    collaborator NETWORK

  • Heidelberg University Hospital Spinal Cord Injury Center

    collaborator UNKNOWN

  • KKS Netzwerk

    collaborator NETWORK

  • University of Zurich

    lead OTHER

Principal Investigators

  • Armin Curt, Prof. · Universität Zürich / University Hospital Balgrist

  • Norbert Weidner, Prof. · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2023-02-02
Completion
2023-02-02

Countries

  • Czechia
  • Germany
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935321 on ClinicalTrials.gov