This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI. The trial will evaluate the safety and tolerability, PK, and effects on motor function and daily life functioning of NG004 compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Klinik für Querschnittgelähmte, Klinikum Bayreuth
Bayreuth, Germany
RECRUITINGBG Universitätsklinikum Bergmannsheil
Bochum, Germany
NOT_YET_RECRUITINGType, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Time frame: From treatment start up to 6 months
NG004 concentration in serum and CSF
Time frame: From treatment start up to 6 months
Effect on neurological recovery according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol as change in ISNCSCI upper extremities motor score (UEMS) and Integrated Neurological Change Score
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery
Time frame: Baseline to 6 months
Effect on daily life functioning as Spinal Cord Independence Measure (SCIM-III)
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.
Time frame: Month 6
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Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
Halle, Germany
BG Klinikum Hamburg
Hamburg, Germany
NOT_YET_RECRUITINGKlinik für Paraplegiologie, Universitätsklinikum Heidelberg
Heidelberg, Germany
NOT_YET_RECRUITINGZentrum für Rückenmarksverletzte, Unfallklinik Murnau
Murnau am Staffelsee, Germany
NOT_YET_RECRUITINGBG Klinik Tübingen
Tübingen, Germany
RECRUITINGREHAB Basel
Basel, Switzerland
RECRUITINGSwiss Paraplegic Centre
Nottwil, Switzerland
RECRUITINGUniversitätsklinik Balgrist
Zurich, Switzerland
RECRUITING