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| Sponsor: | Novartis |
|---|---|
| Information provided by (Responsible Party): | Novartis |
| ClinicalTrials.gov Identifier: | NCT00406016 |
Purpose
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Spinal Cord Injury |
Drug: ATI355 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-center, Open-label, Cohort Study to Assess Feasibility, Acute Safety, Tolerability and Pharmacokinetics of 4 Dose Regimens of Continuous Intrathecal ATI355 Infusion and Two Regimen of Repeated Intrathecal Bolus Injections in Acute Spinal Cord Injury Paraplegic and Tetraplegic Patients |
| Enrollment: | 52 |
| Study Start Date: | May 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: ATI355 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| Canada | |
| Novartis Investigative site | |
| Calgary, Canada | |
| Novartis Investigative site | |
| Montreal, Canada | |
| Novartis Investigative site | |
| Toronto, Canada | |
| Novartis Investigative site | |
| Vancouver, Canada | |
| Germany | |
| Novartis Investigative site | |
| Bad Wildungen, Germany, 34537 | |
| Novartis Investigative site | |
| Bayreuth, Germany, 09445 | |
| Novartis Investigative site | |
| Bochum, Germany, 44789 | |
| Novartis Investigative site | |
| Hamburg, Germany, 21033 | |
| Novartis Investigative site | |
| Heidelberg, Germany, 69118 | |
| Novartis Investigative site | |
| Karlsbad-Lagensteinbach, Germany, 76307 | |
| Novartis Investigative site | |
| Murnau, Germany, 82418 | |
| Novartis Investigative site | |
| Tuebingen, Germany, 72076 | |
| Novartis Investigative site | |
| Ulm, Germany, 89081 | |
| Switzerland | |
| Novartis Investigative Site | |
| Zuerich, Switzerland, 8008 | |
| Novartis Investigative site | |
| Zurich, Switzerland, 8008 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00406016 History of Changes |
| Other Study ID Numbers: | CATI355A2102 |
| Study First Received: | November 30, 2006 |
| Last Updated: | November 2, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Switzerland: Swissmedic Canada: Biologics and Genetic Therapies Directorate. United States: Food and Drug Administration |
|
Acute spinal cord injury; |
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |