NISCI - Nogo Inhibition in Spinal Cord Injury

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

Timeline

Start

2019-05-15

Primary completion

2023-02-02

Completion

2023-02-02

Publications

• Background 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.
• 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.
• 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.
• 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.

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