drugset / Trial / NCT00500812
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-02
- Primary completion
- 2008-12
- Completion
- 2009-02
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper While determining efficacy in a small open-label study is not possible PMID 23844986 ↗
Publications
- Results McKerracher L, Anderson KD. Analysis of recruitment and outcomes in the phase I/IIa Cethrin clinical trial for acute spinal cord injury. J Neurotrauma. 2013 Nov 1;30(21):1795-804. doi: 10.1089/neu.2013.2909. Epub 2013 Oct 1.
- Results Fehlings MG, Theodore N, Harrop J, Maurais G, Kuntz C, Shaffrey CI, Kwon BK, Chapman J, Yee A, Tighe A, McKerracher L. A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury. J Neurotrauma. 2011 May;28(5):787-96. doi: 10.1089/neu.2011.1765.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cethrin | Protein / enzyme biologic | 0.3 mg | Other |
| Subject | Cethrin | Protein / enzyme biologic | 1 mg | Other |
| Subject | Cethrin | Protein / enzyme biologic | 3 mg | Other |
| Subject | Cethrin | Protein / enzyme biologic | 6 mg | Other |
| Subject | Cethrin | Protein / enzyme biologic | 9 mg | Other |