This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.
Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
Time frame: Baseline to 6 Months
ASIA Total Motor Score Recovery
Time frame: Baseline to 6 Months
ASIA Impairment Scale (AIS) Grade Recovery
Time frame: Baseline to 6 Months
Motor Neurological Level Recovery
Time frame: Baseline to 6 Months
ASIA Sensory Score Recovery
Time frame: Baseline to 6 Months
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
Time frame: 6 Months
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time frame: 6 Months
Incidence of Adverse Events
Time frame: 0-6 Months
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