Overview
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Other significant pre-existing or current severe systemic disease
- History of or an episode of multiple sclerosis or Guillain-Barre syndrome
- History of recent meningitis or meningoencephalitis
- History of refractory epilepsy
- Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
- Presence of any unstable medical or psychiatric condition
- Drug dependence any time within the last 6 months before Screening
- Pregnant or nursing women
- History of a life-threatening allergic or immune-mediated reaction
- 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
