NCT00610337

Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

A Phase IIb, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Safety and Efficacy of Intraoperative Epidural Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioAxone BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 62 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury. This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®. This adaptive study has been designed to efficiently identify the safest and most effective dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack of effective treatments for SCI, an improvement in motor ability or activities of daily living in these subjects would be a great advancement in the treatment of SCI.

Conditions

• Acute Cervical Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Cethrin® (BA-210)	Intraoperative epidural administration during spinal decompression surgery
PROCEDURE	placebo	Spinal decompression surgery without administration of Cethrin® BA-210

Timeline

• First posted: 2008-02-07
• Last updated: 2014-01-17