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NISCI - Nogo Inhibition in Spinal Cord Injury (NISCI)

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ClinicalTrials.gov Identifier: NCT03935321
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : July 12, 2019
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

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 Intervention/treatment Phase
Spinal Cord Injury, Acute Drug: NG-101 Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 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 15, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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




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


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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935321


Contacts
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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
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Czechia
Spinal Cord Unit, University Hospital Motol Not yet recruiting
Praha, Czechia
Contact: Jiri Kriz, Dr.       nisci@fnmotol.cz   
Germany
Klinik für Querschnittgelähmte, Klinikum Bayreuth Not yet recruiting
Bayreuth, Germany
Contact: Michaela Mayer, SC       nisci@klinikum-bayreuth.de   
Behandlungszentrum für Rückenmarkverletzte, Unfallkrankenhaus Berlin Not yet recruiting
Berlin, Germany
Contact: Thomas Liebscher, Dr. med.       rmv-studien@ukb.de   
Abteilung für Rückenmarkverletzte, BG Universitätsklinikum Bergmannsheil gGmbH Not yet recruiting
Bochum, Germany
Contact: Dennis Grasmücke, Dr. med.       nisci@bergmannsheil.de   
Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost Not yet recruiting
Halle, Germany
Contact: Klaus Röhl, Dr. med.       nisci@bergmannstrost.de   
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Heutehaus Laura       nisci.ouk@med.uni-heidelberg.de   
Contact: Langpape Annette       nisci.ouk@med.uni-heidelberg.de   
Zentrum für Tetra- und Paraplegie, Orthopädische Klinik Hessisch Lichtenau gGmbH Not yet recruiting
Hessisch Lichtenau, Germany
Contact: Sabine Hüge, SN       nisci@lichtenau-ev.de   
Zentrum für Rückenmarksverletzte, Unfallklinik Murnau Not yet recruiting
Murnau Am Staffelsee, Germany
Contact: Orpheus Mach       nisci@bgu-murnau.de   
Italy
Center for Neurorehabilitation, Santa Lucia Foundation Not yet recruiting
Rome, Italy
Contact: Marcella Masciullo, Dr. PhD       nisci@hsantalucia.it   
Spain
Center for Neurorehabilitation, Fundacio Institut Guttmann Not yet recruiting
Barcelona, Spain
Contact: Jesus Benito, Dr.       nisci@guttmann.com   
Switzerland
Rehab Basel Recruiting
Basel, Switzerland
Contact: Kerstin Hug, Dr. med.       nisci@rehab.ch   
Contact: Carmen Rinaldo, SN       nisci@rehab.ch   
Schweizer Paraplegikerzentrum Recruiting
Nottwil, Switzerland
Contact: Evelyn Rickenbacher, SC       nisci@paraplegie.ch   
Contact: Daniel Schliessmann, SC       nisci@paraplegie.ch   
Universitätsklinik Balgrist Recruiting
Zürich, Switzerland, 8008
Contact: Andrea Prusse    +41 44 386 59 70    nisci@balgrist.ch   
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
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Principal Investigator: Armin Curt, Prof. Universität Zürich / University Hospital Balgrist
Principal Investigator: Norbert Weidner, Prof. University Hospital Heidelberg

Publications:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03935321     History of Changes
Other Study ID Numbers: EudraCT No. 2016-001227-31
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
Tetraplegia
Trauma
Upper limbs function

Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System