CClinicalTrials.gg
Sign In
CompletedNCT03935321NISCIUpdated Apr 4, 2023

NISCI - Nogo Inhibition in Spinal Cord Injury

A Phase 2 interventional study of NG-101 and Placebos in Spinal Cord Injury, Acute, sponsored by University of Zurich. Completed at 13 sites in 4 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by University of Zurich · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Spinal Cord Injury, Acute

Keywords

  • Tetraplegia
  • Trauma
  • Upper limbs function
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 129 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
129 participants (actual)

Study arms

  • Active comparator
    Patients with acute cervical spinal cord injury: NG-101

    Drug: NG-101

  • Placebo comparator
    Patients with acute cervical spinal cord injury: Placebo

    Drug: Placebos

Interventions

  • DrugNG-101

    6 intrathecal bolus injections, each of 45mg

  • DrugPlacebos

    6 intrathecal bolus injections, each of 45mg

06

What researchers measure

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

07

Study locations

13 sites
  • Spinal Cord Unit, University Hospital Motol
    Praha, Czechia
  • 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, Germany
  • Center for Neurorehabilitation, Fundacio Institut Guttmann
    Barcelona, Spain
  • Rehab Basel
    Basel, Switzerland
  • Schweizer Paraplegikerzentrum
    Nottwil, Switzerland
  • Universitätsklinik Balgrist
    Zürich, 8008, Switzerland
08

References and documents

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. PubMed 29869587 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03935321
Lead sponsor
University of Zurich
Collaborators
EMSCI.org, State Secretariat for Education Research and Innovation, Switzerland, Horizon 2020 - European Commission, Foundation Wings For Life, Swiss Paraplegic Research, Nottwil, Heidelberg University Hospital Spinal Cord Injury Center, KKS Netzwerk
Responsible party
Sponsor
First posted
May 2, 2019
Start date
May 15, 2019
Primary completion
Feb 2, 2023
Completion
Feb 2, 2023
Last update
Apr 4, 2023

Study contacts

Armin Curt, Prof.
principal investigator · Universität Zürich / University Hospital Balgrist
Norbert Weidner, Prof.
principal investigator · University Hospital Heidelberg

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Spinal Cord Injuries→

Other studies from this sponsor

University of Zurich

Start the discussion