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出境医 / 临床实验 / NISCI - Nogo Inhibition in Spinal Cord Injury (NISCI)
NISCI - Nogo Inhibition in Spinal Cord Injury (NISCI)
Study Description
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 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 114 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 : | December 30, 2022 |
| Estimated Study Completion Date : | December 30, 2023 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- Change of effect on motor and sensory function according to the ISNCSCI protocol [ Time Frame: Change from screening at day 168 ]
- Change of effect on autonomic dysfunction measured by bladder diary [ Time Frame: Change from screening at day 168 ]
- 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 ]
- Change of effect on autonomic dysfunction as measured by bladder function assessment [ Time Frame: Change from screening at day 168 ]
- Change of effect on functioning, evaluated by the Spinal Cord Independence Measure (SCIM-III) [ Time Frame: Change from baseline at day 168 ]
- 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 ]
- Change of effect on the Walking Index for Spinal Cord Injury (WISCI [ Time Frame: Change from baseline at day 168 ]
- Change of effect on 10 meter walk test (10mWT) [ Time Frame: Change from baseline at day 168 ]
- Change of effect on 6-minute walking test (6MWT) [ Time Frame: Change from baseline at day 168 ]
- Change of effects on nerve conducting velocity [ Time Frame: Change from screening at day 168 ]
- Change of effects on somatosensory evoked potentials [ Time Frame: Change from screening at day 168 ]
- Evaluation of concentration NG-101 in serum (pharmacokinetics) [ Time Frame: Change from day 0 at day 84 ]
- Evaluation of concentration NG-101 in CSF (pharmacokinetics) [ Time Frame: Change from day 0 at day 84 ]
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| 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 | Recruiting |
| Bayreuth, Germany | |
| Contact: Michaela Mayer, SC nisci@klinikum-bayreuth.de | |
| Behandlungszentrum für Rückenmarkverletzte, Unfallkrankenhaus Berlin | Recruiting |
| Berlin, Germany | |
| Contact: Thomas Liebscher, Dr. med. rmv-studien@ukb.de | |
| Abteilung für Rückenmarkverletzte, BG Universitätsklinikum Bergmannsheil gGmbH | Recruiting |
| Bochum, Germany | |
| Contact: Dennis Grasmücke, Dr. med. nisci@bergmannsheil.de | |
| Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost | Recruiting |
| Halle, Germany | |
| Contact: Klaus Röhl, Dr. med. nisci@bergmannstrost.de | |
| Klinik für Paraplegiologie, Universitätsklinikum Heidelberg | 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 | Recruiting |
| Hessisch Lichtenau, Germany | |
| Contact: Sabine Hüge, SN nisci@lichtenau-ev.de | |
| Zentrum für Rückenmarksverletzte, Unfallklinik Murnau | Recruiting |
| Murnau Am Staffelsee, Germany | |
| Contact: Orpheus Mach nisci@bgu-murnau.de | |
| BG Klinik Tübingen | Recruiting |
| Tübingen, Germany | |
| Contact: Marie Reumann, Dr. nisci@bgu-tuebingen.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 | 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
| Principal Investigator: | Armin Curt, Prof. | Universität Zürich / University Hospital Balgrist | |
| Principal Investigator: | Norbert Weidner, Prof. | University Hospital Heidelberg |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 25, 2019 | ||||||||
| First Posted Date ICMJE | May 2, 2019 | ||||||||
| Last Update Posted Date | April 23, 2021 | ||||||||
| Actual Study Start Date ICMJE | May 15, 2019 | ||||||||
| Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE |
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | NISCI - Nogo Inhibition in Spinal Cord Injury | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Spinal Cord Injury, Acute | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
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| 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. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
114 | ||||||||
| Original Estimated Enrollment ICMJE |
132 | ||||||||
| Estimated Study Completion Date ICMJE | December 30, 2023 | ||||||||
| Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Czechia, Germany, Italy, Spain, Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03935321 | ||||||||
| Other Study ID Numbers ICMJE | EudraCT No. 2016-001227-31 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Zurich | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Zurich | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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