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NISCI - Nogo Inhibition in Spinal Cord Injury

  • Clinicaltrials.gov identifier

    NCT03935321

  • Recruitment Status

    Recruiting

  • First Posted

    May 2, 2019

  • Last update posted

    April 23, 2021

Study Description

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

  • Condition or Disease:Spinal Cord Injury, Acute
  • Intervention/Treatment: Drug: Placebos
    Drug: NG-101
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 114 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2023

Arms and interventions

Arm Intervention/treatment
Active Comparator: Patients with acute cervical spinal cord injury: NG-101
Drug: NG-101
6 intrathecal bolus injections, each of 45mg
Placebo Comparator: Patients with acute cervical spinal cord injury: Placebo
Drug: Placebos
6 intrathecal bolus injections, each of 45mg

Outcome Measures

  • Primary Outcome Measures: 1. 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 ]
  • Secondary Outcome Measures: 1. Change of effects on somatosensory evoked potentials [ Time Frame: Change from screening at day 168 ]
  • 2. Evaluation of concentration NG-101 in serum (pharmacokinetics) [ Time Frame: Change from day 0 at day 84 ]
  • 3. Evaluation of concentration NG-101 in CSF (pharmacokinetics) [ Time Frame: Change from day 0 at day 84 ]
  • 4. 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 ]
  • 5. Change of effect on the Walking Index for Spinal Cord Injury (WISCI [ Time Frame: Change from baseline at day 168 ]
  • 6. Change of effect on 10 meter walk test (10mWT) [ Time Frame: Change from baseline at day 168 ]
  • 7. Change of effect on 6-minute walking test (6MWT) [ Time Frame: Change from baseline at day 168 ]
  • 8. Change of effect on autonomic dysfunction as measured by bladder function assessment [ Time Frame: Change from screening at day 168 ]
  • 9. Change of effect on functioning, evaluated by the Spinal Cord Independence Measure (SCIM-III) [ Time Frame: Change from baseline at day 168 ]
  • 10. Change of effects on nerve conducting velocity [ Time Frame: Change from screening at day 168 ]
  • 11. Change of effect on motor and sensory function according to the ISNCSCI protocol [ Time Frame: Change from screening at day 168 ]
  • 12. Change of effect on autonomic dysfunction measured by bladder diary [ Time Frame: Change from screening at day 168 ]
  • 13. 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 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Andrea Prusse, SC +41 44 386 59 70 nisci@balgrist.ch

Contact: Iris Krüsi, SN +41 44 510 72 22 nisci@balgrist.ch

Locations

Czechia
Spinal Cord Unit, University Hospital Motol
Praha

Germany
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

Italy
Center for Neurorehabilitation, Santa Lucia Foundation
Rome

Spain
Center for Neurorehabilitation, Fundacio Institut Guttmann
Barcelona

Switzerland
Rehab Basel
Basel

Switzerland
Schweizer Paraplegikerzentrum
Nottwil

Switzerland
Universitätsklinik Balgrist
Zürich

Sponsors and Collaborators

University of Zurich

EMSCI.org

State Secretariat for Education Research and Innovation, Switzerland

Horizon 2020 - European Commission

Foundation Wings For Life

Swiss Paraplegic Research

Heidelberg University Hospital Spinal Cord Injury Center

KKS Netzwerk

Investigators

Principal Investigator: Armin Curt, Prof. Universität Zürich / University Hospital Balgrist

Principal Investigator: Norbert Weidner, Prof. University Hospital Heidelberg

More Information