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| Sponsor: | Alseres Pharmaceuticals, Inc |
|---|---|
| Collaborator: |
(Formerly Boston Life Sciences) |
| Information provided by: | Alseres Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00500812 |
Purpose
This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a complete thoracic injury. Dose levels from 0.3 mg - 9 mg of Cethrin will be administered.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Drug: BA-210 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase I/IIa Dose-Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BA-210 and the Neurological Status of Patients Following Administration of a Single Extradural Application of Cethrin During Surgery for Acute Thoracic and Cervical Spinal Cord Injury |
| Enrollment: | 48 |
| Study Start Date: | February 2005 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be enrolled in this study only if they meet all of the following criteria:
Exclusion Criteria:
Patients will not be enrolled in this study if they meet one of the following criteria:
Hemophilia or other bleeding abnormality as defined by:
Contacts and Locations| United States, Arizona | |
| St. Joseph's Hospital & Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Ohio | |
| University of Cincinnati Mayfield Clinic and Spine Institute | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Virginia | |
| Univ.of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| University of Washington Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Canada, Ontario | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T2S8 | |
| Sunnybrooke Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N3M5 | |
| Canada, Quebec | |
| Hopital du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J1C5 | |
| Principal Investigator: | Michael J. Fehlings, MD, PhD, FRCSC, FACS | Univestity Health Network, Toronto Western |
More Information
| Responsible Party: | Alseres Pharmaceuticals ( Susan Flint, Senior Vice President, Drug Development ) |
| Study ID Numbers: | BA-210-101 |
| Study First Received: | July 11, 2007 |
| Last Updated: | May 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00500812 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
therapeutic therapeutique therapy motor sensory neurotherapy Bioaxone TRAUMA INJURY SPINAL THORACIC CERVICAL PARALYSIS PARAPLEGIA TETRAPLEGIA |
ACUTE SURGERY NEUROLOGY NEURO NEUROSURGERY RESEARCH NEURONS NERVES SCI CORD VERTEBRA DECOMPRESSION FIXATION FUSION REHABILITATION |
|
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |