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Completed

NCT Number: NCT03935321

NISCI - Nogo Inhibition in Spinal Cord Injury

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

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Key information

Conditions

Spinal Cord Injury, Acute Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spinal Cord Unit, University Hospital Motol, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NG-101

Drug

6 intrathecal bolus injections, each of 45mg

Placebos

Drug

6 intrathecal bolus injections, each of 45mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • EMSCI.org
  • Foundation Wings For Life
  • Heidelberg University Hospital Spinal Cord Injury Center
  • Horizon 2020 - European Commission
  • KKS Netzwerk
  • State Secretariat for Education Research and Innovation, Switzerland
  • Swiss Paraplegic Research, Nottwil

Registry information

Official study 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

Acronym: NISCI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 2, 2019
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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