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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
6 intrathecal bolus injections, each of 45mg
6 intrathecal bolus injections, each of 45mg
Spinal Cord Unit, University Hospital Motol
Prague, Czechia
Klinik für Querschnittgelähmte, Klinikum Bayreuth
Bayreuth, Germany
Behandlungszentrum für Rückenmarkverletzte, Unfallkrankenhaus Berlin
Berlin, Germany
Abteilung für Rückenmarkverletzte, BG Universitätsklinikum Bergmannsheil gGmbH
Bochum, Germany
Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
Halle, Germany
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
Heidelberg, Germany
Zentrum für Tetra- und Paraplegie, Orthopädische Klinik Hessisch Lichtenau gGmbH
Hessisch Lichtenau, Germany
Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
Murnau am Staffelsee, Germany
BG Klinik Tübingen
Tübingen, Germany
Center for Neurorehabilitation, Fundacio Institut Guttmann
Barcelona, Spain
...and 3 more locations
Change of upper extremity motor scores (UEMS) according to the International Standards for the Neurological Classification of Spinal Cord Injury
Time frame: Change from screening at day 168
Change of effect on motor and sensory function according to the ISNCSCI protocol
Time frame: Change from screening at day 168
Change of effect on autonomic dysfunction measured by bladder diary
Time frame: Change from screening at day 168
Change of effect on quality life of patients with neuro-urological disorders as measured by Qualiveen questionnaire
Time frame: Change from screening at day 168
Change of effect on autonomic dysfunction as measured by bladder function assessment
Time frame: Change from screening at day 168
Change of effect on functioning, evaluated by the Spinal Cord Independence Measure (SCIM-III)
Time frame: Change from baseline at day 168
Change of effect on hand/upper limb function as assessed by the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time frame: Change from baseline at day 168
Change of effect on the Walking Index for Spinal Cord Injury (WISCI
Time frame: Change from baseline at day 168
Change of effect on 10 meter walk test (10mWT)
Time frame: Change from baseline at day 168
Change of effect on 6-minute walking test (6MWT)
Time frame: Change from baseline at day 168
Change of effects on nerve conducting velocity
Time frame: Change from screening at day 168
Change of effects on somatosensory evoked potentials
Time frame: Change from screening at day 168
Evaluation of concentration NG-101 in serum (pharmacokinetics)
Time frame: Change from day 0 at day 84
Evaluation of concentration NG-101 in CSF (pharmacokinetics)
Time frame: Change from day 0 at day 84
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