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.
Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) B, C and D at Screening
4-28 days post-injury and no earlier than 4 days after spinal surgery
No required mechanical ventilation or patients that do not completely depend on mechanical ventilation
Hemodynamically and clinical stable patient according to the acute SCI condition at baseline
Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
Multiple levels of clinically relevant spinal cord lesions
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
Parallel
NG004
Drugrepeated intrathecal injections of NG004 within 30 days
Placebo
Other interventionrepeated intrathecal injections of Placebo within 30 days
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
NG004 concentration in serum and CSF
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
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.
Effect on Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP): strength and prehension performance
The GRASSP is a validated clinical measure of hand function in tetraplegic patients and can assess changes in impairment over time. The GRASSP (Version 2) consists of 4 subtests. The subtest strength (manual muscle testing of 10 muscles of the upper limb) and the subtest prehension performance (grasping test with 4 activities of daily living) will be performed.
Effect on the Walking Index for Spinal Cord Injury (WISCI II)
WISCI II is a 21-item hierarchical scale of walking based on physical assistance, need of braces and devices, with an ordinal range from 0 (unable to walk) to 20 (walking without assistance for at least 10 meters).
Effect on 10-meter walking test (10mWT)
10mWT is a quantitative measurement of lower extremity function. The patient shall walk a set distance (10 meters) at preferred walking speed. The distance covered, the time taken, and the assistance used will be recorded.
Effect on 6-minute walking test (6MWT)
6MWT is a test used to determine the locomotor performance. Patients are instructed to walk as far as possible during 6 minutes, with rests being taken whenever required. The distance covered in time or until abort, the walking time until abort, and the number of rests are assessed.
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