Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.