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NISCI - Nogo Inhibition in Spinal Cord Injury (NISCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03935321
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : August 25, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date August 25, 2022
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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 neurophysiological parameters (nerve conducting velocity, 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NISCI - Nogo Inhibition in Spinal Cord Injury
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury, Acute
Intervention  ICMJE
  • Drug: NG-101
    6 intrathecal bolus injections, each of 45mg
  • Drug: Placebos
    6 intrathecal bolus injections, each of 45mg
Study Arms  ICMJE
  • Active Comparator: Patients with acute cervical spinal cord injury: NG-101
    Intervention: Drug: NG-101
  • Placebo Comparator: Patients with acute cervical spinal cord injury: Placebo
    Intervention: Drug: Placebos
Publications * Kucher K, Johns D, Maier D, Abel R, Badke A, Baron H, Thietje R, Casha S, Meindl R, Gomez-Mancilla B, Pfister C, Rupp R, Weidner N, Mir A, Schwab ME, Curt A. First-in-Man Intrathecal Application of Neurite Growth-Promoting Anti-Nogo-A Antibodies in Acute Spinal Cord Injury. Neurorehabil Neural Repair. 2018 Jun;32(6-7):578-589. doi: 10.1177/1545968318776371. Epub 2018 Jun 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2020)
114
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2019)
132
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Spain,   Switzerland
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT03935321
Other Study ID Numbers  ICMJE EudraCT No. 2016-001227-31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Zurich
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Zurich
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Armin Curt, Prof. Universität Zürich / University Hospital Balgrist
Principal Investigator: Norbert Weidner, Prof. University Hospital Heidelberg
PRS Account University of Zurich
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP