Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI
Phase 1
Completed
- Conditions
- Acute Spinal Cord Injury
- Interventions
- Drug: ATI355
- Registration Number
- NCT00406016
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ATI355 -
- Primary Outcome Measures
Name Time Method 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. 1 year
- Secondary Outcome Measures
Name Time Method Immunogenicity of ATI355 in acute spinal cord injury patients up to one year. 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. 1 year
Trial Locations
- Locations (2)
Novartis Investigative Site
🇨🇭Zuerich, Switzerland
Novartis Investigative site
🇨🇭Zurich, Switzerland