NISCI - Nogo Inhibition in Spinal Cord Injury

Phase 2

Completed

• Conditions: Spinal Cord Injury, Acute
• Interventions: Drug: Placebos; Drug: NG-101

• Registration Number: NCT03935321
• Lead Sponsor: University of Zurich

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-02
• Study Start: 2019-05-15
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Acute cervical spinal cord injury (SCI) (Neurological level of injury C1-C8 with confirmed classification of ASIA impairment scale (AIS) A-D at screening and predicted upper extremities motor score (UEMS) recovery of less than 41/50 (according to the URP prediction model)
• 4-28 days post-injury
• No required mechanical ventilation or patients that not completely depend on mechanical ventilation
• Hemodynamically and clinical stable patient according to the acute SCI condition at baseline
• Written informed consent
• Cooperation and willingness to complete all aspects of the study
• Ability of subject to understand character and individual consequences of the study

Exclusion Criteria

• Complete anatomical transection confirmed by magnetic resonance imaging (MRI)
• Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
• Major brachial or lumbar plexus damage/trauma
• Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function
• Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastorintestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
• History of or an acute episode of Guillain-Barre syndrome
• History of recent (6 months) meningitis or meningoencephalitis
• History of refractory epilepsy
• History of or current autoimmune disease
• Patients with uncontrolled bleeding diathesis and/or who require concomitant treatment with coumarin anticoagulant
• Presence of any unstable medical or psychiatric condition
• Drug dependence any time during the 6 month's preceding study entry
• Pregnant or nursing women
• History of a life-threatening allergic or immune mediated reaction
• Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
• Patients who are unconscious
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with acute cervical spinal cord injury: Placebo	Placebos	-
Patients with acute cervical spinal cord injury: NG-101	NG-101	-

Primary Outcome Measures

Name	Time	Method
Change of upper extremity motor scores (UEMS) according to the International Standards for the Neurological Classification of Spinal Cord Injury	Change from screening at day 168

Secondary Outcome Measures

Name	Time	Method
Change of effect on motor and sensory function according to the ISNCSCI protocol	Change from screening at day 168
Change of effect on autonomic dysfunction as measured by bladder function assessment	Change from screening at day 168
Change of effect on the Walking Index for Spinal Cord Injury (WISCI	Change from baseline at day 168
Change of effect on quality life of patients with neuro-urological disorders as measured by Qualiveen questionnaire	Change from screening at day 168
Change of effect on 10 meter walk test (10mWT)	Change from baseline at day 168
Change of effect on functioning, evaluated by the Spinal Cord Independence Measure (SCIM-III)	Change from baseline at day 168
Change of effect on autonomic dysfunction measured by bladder diary	Change from screening at day 168
Evaluation of concentration NG-101 in serum (pharmacokinetics)	Change from day 0 at day 84
Change of effect on hand/upper limb function as assessed by the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	Change from baseline at day 168
Change of effect on 6-minute walking test (6MWT)	Change from baseline at day 168
Evaluation of concentration NG-101 in CSF (pharmacokinetics)	Change from day 0 at day 84
Change of effects on nerve conducting velocity	Change from screening at day 168
Change of effects on somatosensory evoked potentials	Change from screening at day 168

Trial Locations

Locations (13)

Klinik für Querschnittgelähmte, Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

Spinal Cord Unit, University Hospital Motol; 🇨🇿 Praha, Czechia

Abteilung für Rückenmarkverletzte, BG Universitätsklinikum Bergmannsheil gGmbH; 🇩🇪 Bochum, Germany

Behandlungszentrum für Rückenmarkverletzte, Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost; 🇩🇪 Halle, Germany

Zentrum für Tetra- und Paraplegie, Orthopädische Klinik Hessisch Lichtenau gGmbH; 🇩🇪 Hessisch Lichtenau, Germany

Klinik für Paraplegiologie, Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

BG Klinik Tübingen; 🇩🇪 Tübingen, Germany

Center for Neurorehabilitation, Fundacio Institut Guttmann; 🇪🇸 Barcelona, Spain

Schweizer Paraplegikerzentrum; 🇨🇭 Nottwil, Switzerland

Universitätsklinik Balgrist; 🇨🇭 Zürich, Switzerland

Rehab Basel; 🇨🇭 Basel, Switzerland

Zentrum für Rückenmarksverletzte, Unfallklinik Murnau; 🇩🇪 Murnau Am Staffelsee, Germany