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Sponsors and Collaborators: |
Alseres Pharmaceuticals, Inc (Formerly Boston Life Sciences) |
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Information provided by: | Alseres Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00500812 |
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 |
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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 |
Estimated Enrollment: | 50 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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:
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 |
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: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00500812 |
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 |
Paralysis Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries Paraplegia |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Quadriplegia |
Nervous System Diseases |