|
|
|
|
|
|
Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00406016 |
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 5 dose regimens of ATI355 in acute spinal cord injury patients
Condition | Intervention | Phase |
Acute Spinal Cord Injury |
Drug: ATI355 |
Phase I |
MedlinePlus related topics: | Spinal Cord Injuries |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Multi-Center,Open-Label,Cohort Study to Assess Feasibility,Acute Safety,Tolerability and Pharmacokinetics of 4 Dose of Continuous Intrath. ATI355 Infusion and 1 of Repeated Intrath. Bolus Inj. in Acute SCI Para- and Tetraplegic Patients |
Estimated Enrollment: | 35 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | October 2009 |
Arms | Assigned Interventions |
1: Experimental | Drug: ATI355 |
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 5 dose regimens of ATI355 in acute spinal cord injury patients
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion criteria
Exclusion criteria
Contact: Novartis Pharmaceuticals | 41 61 324 1111 |
Canada | |||||
Novartis Investigative site | Not yet recruiting | ||||
Toronto, Canada | |||||
Contact: Novartis Pharmaceuticals +41 61 324 1111 | |||||
Novartis Investigative site | Not yet recruiting | ||||
Vancouver, Canada | |||||
Contact: Novartis Pharmaceuticals +41 61 324 1111 | |||||
Novartis Investigative site | Active, not recruiting | ||||
Montreal, Canada | |||||
Novartis Investigative site | Active, not recruiting | ||||
Calgary, Canada | |||||
Germany | |||||
Novartis Investigative site | Recruiting | ||||
Heidelberg, Germany, 69118 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Novartis Investigative site | Recruiting | ||||
Bayreuth, Germany, 09445 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Novartis Investigative site | Recruiting | ||||
Karlsbad-Lagensteinbach, Germany, 76307 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Novartis Investigative site | Recruiting | ||||
Bochum, Germany, 44789 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Novartis Investigative site | Recruiting | ||||
Murnau, Germany, 82418 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Novartis Investigative site | Active, not recruiting | ||||
Ulm, Germany, 89081 | |||||
Novartis Investigative site | Active, not recruiting | ||||
Bad Wildungen, Germany, 34537 | |||||
Novartis Investigative site | Recruiting | ||||
Tuebingen, Germany, 72076 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Novartis Investigative site | Recruiting | ||||
Hamburg, Germany, 21033 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 | |||||
Switzerland | |||||
Novartis Investigative site | Recruiting | ||||
Zurich, Switzerland, 8008 | |||||
Contact: Novartis Pharmaceuticals 41 61 324 1111 |
Novartis |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CATI355A2102 |
First Received: | November 30, 2006 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00406016 |
Health Authority: | Germany: Paul-Ehrlich-Institut; Switzerland: Swissmedic; Canada: Biologics and Genetic Therapies Directorate. |
|
|
|
|