A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
NCT00500812 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2016-04-14
Summary
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.
Conditions
- Spinal Cord Injury
Interventions
- DRUG
-
Cethrin
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Principal Investigators
-
Michael J. Fehlings, MD, PhD, FRCSC, FACS · Univestity Health Network, Toronto Western
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
- Primary Completion
- 2008-12-31
- Completion
- 2009-02-28
Countries
- United States
- Canada
Study Locations
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