This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Novartis Investigative site
Calgary, Canada
Novartis Investigative site
Montreal, Canada
Novartis Investigative site
Toronto, Canada
Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits.
Time frame: 1 year
Immunogenicity of ATI355 in acute spinal cord injury patients up to one year.
Time frame: 1 year
Early potential signal of efficacy by the American Spinal Cord Injury Association (ASIA) protocol and pharmacodynamic changes assessed by electrophysiology tests for up to one year.
Time frame: 1 year
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Novartis Investigative site
Vancouver, Canada
Novartis Investigative site
Bad Wildungen, Germany
Novartis Investigative site
Bayreuth, Germany
Novartis Investigative site
Bochum, Germany
Novartis Investigative site
Hamburg, Germany
Novartis Investigative site
Heidelberg, Germany
Novartis Investigative site
Karlsbad-Lagensteinbach, Germany
...and 4 more locations