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Spinal Cord Injury, AcutePhase 2NISCINCT03935321

NISCI - Nogo Inhibition in Spinal Cord Injury

A Phase 2 study testing NG-101 in people with Spinal Cord Injury, Acute, run by University of Zurich at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Cord Injury, Acute
What is being tested?
NG-101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
13 sitesin 4 countries
Study dates
15 May 2019to 2 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Germany8 sites

  • Klinik für Querschnittgelähmte, Klinikum Bayreuth

    Bayreuth

  • Behandlungszentrum für Rückenmarkverletzte, Unfallkrankenhaus Berlin

    Berlin

  • Abteilung für Rückenmarkverletzte, BG Universitätsklinikum Bergmannsheil gGmbH

    Bochum

  • Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost

    Halle

  • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg

    Heidelberg

  • Zentrum für Tetra- und Paraplegie, Orthopädische Klinik Hessisch Lichtenau gGmbH

    Hessisch Lichtenau

  • Zentrum für Rückenmarksverletzte, Unfallklinik Murnau

    Murnau am Staffelsee

  • BG Klinik Tübingen

    Tübingen

Other trials in Germany

Switzerland3 sites

  • Rehab Basel

    Basel

  • Schweizer Paraplegikerzentrum

    Nottwil

  • Universitätsklinik Balgrist

    Zurich, 8008

Other trials in Switzerland

Czechia1 site

  • Spinal Cord Unit, University Hospital Motol

    Prague

Other trials in Czechia

Spain1 site

  • Center for Neurorehabilitation, Fundacio Institut Guttmann

    Barcelona

Other trials in Spain

About this study

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

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

Being tested
NG-101, Placebos
Keywords
Tetraplegia, Trauma, Upper limbs function
Medical subject headings
Spinal Cord Injuries, Quadriplegia, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NG-101Drug

    6 intrathecal bolus injections, each of 45mg

  • PlacebosDrug

    6 intrathecal bolus injections, each of 45mg

Study groups in NCT03935321
Study groupRoleWhat they receive
Patients with acute cervical spinal cord injury: NG-101Active comparatorNot described
Receives: Drug: NG-101
Patients with acute cervical spinal cord injury: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of upper extremity motor scores (UEMS) according to the International Standards for the Neurological Classification of Spinal Cord Injury

    Measured: Change from screening at day 168

Secondary outcomes (13)

  1. Change of effect on motor and sensory function according to the ISNCSCI protocol

    Measured: Change from screening at day 168

  2. Change of effect on autonomic dysfunction measured by bladder diary

    Measured: Change from screening at day 168

  3. Change of effect on quality life of patients with neuro-urological disorders as measured by Qualiveen questionnaire

    Measured: Change from screening at day 168

  4. Change of effect on autonomic dysfunction as measured by bladder function assessment

    Measured: Change from screening at day 168

  5. Change of effect on functioning, evaluated by the Spinal Cord Independence Measure (SCIM-III)

    Measured: 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)

    Measured: Change from baseline at day 168

  7. Change of effect on the Walking Index for Spinal Cord Injury (WISCI

    Measured: Change from baseline at day 168

  8. Change of effect on 10 meter walk test (10mWT)

    Measured: Change from baseline at day 168

  9. Change of effect on 6-minute walking test (6MWT)

    Measured: Change from baseline at day 168

  10. Change of effects on nerve conducting velocity

    Measured: Change from screening at day 168

  11. Change of effects on somatosensory evoked potentials

    Measured: Change from screening at day 168

  12. Evaluation of concentration NG-101 in serum (pharmacokinetics)

    Measured: Change from day 0 at day 84

  13. Evaluation of concentration NG-101 in CSF (pharmacokinetics)

    Measured: Change from day 0 at day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2019
  2. Study start15 May 2019
  3. Primary completion2 Feb 2023
  4. Study completion2 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03935321
Sponsor's protocol ID
EudraCT No. 2016-001227-31
Acronym
NISCI
Status last verified
Apr 2023
First submitted
25 Mar 2019
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Farner L, Scheuren PS, Sharifi K, Emmenegger TM, Seif M, Hubli M, Schubert M, Bolliger M, Rupp R, Weidner N, Abel R, Maier D, Rohl K, Baumberger M, Hund-Georgiadis M, Saur M, Benito J, Rehahn K, Aach M, Badke A, Kriz J, Killeen T, Thompson AJ, Weiskopf N, Schwab ME, Curt A, Freund P; Nogo Inhibition in Spinal Cord Injury (NISCI) Study Group. Anti-Nogo-A NG101 treatment induces changes in spinal cord micro- and macrostructure following spinal cord injury. Nat Commun. 2026 May 12;17(1):4197. doi: 10.1038/s41467-026-71412-0.

    PubMed 42120375

  • Giagiozis M, Lerch I, Linke AD, Jutzeler CR, Rupp R, Abel R, Benito-Penalva J, Waldmann J, Maier D, Baumberger M, Kriz J, Badke A, Hund-Georgiadis M, Weidner N, Demko L, Curt A. Feasibility and Sensitivity of Wearable Sensors for Daily Activity Monitoring in Spinal Cord Injury Trials. Neurorehabil Neural Repair. 2025 Oct;39(10):814-825. doi: 10.1177/15459683251352556. Epub 2025 Jul 10.

    PubMed 40637209

  • Weidner N, Abel R, Maier D, Rohl K, Rohrich F, Baumberger M, Hund-Georgiadis M, Saur M, Benito J, Rehahn K, Aach M, Badke A, Kriz J, Barkovits K, Killeen T, Farner L, Seif M, Hubli M, Marcus K, Maurer MA, Robert B, Rupp R, Scheuren PS, Schubert M, Schuld C, Sina C, Steiner B, Weis T, Hug A, Bolliger M, Weiskopf N, Freund P, Hothorn T, Schwab ME, Curt A; Nogo Inhibition in Spinal Cord Injury Study Group. Safety and efficacy of intrathecal antibodies to Nogo-A in patients with acute cervical spinal cord injury: a randomised, double-blind, multicentre, placebo-controlled, phase 2b trial. Lancet Neurol. 2025 Jan;24(1):42-53. doi: 10.1016/S1474-4422(24)00447-2.

    PubMed 39706632

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NG-101 in people with Spinal Cord Injury, Acute, run by University of Zurich at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Switzerland, Czechia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03935321, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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