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

NCT00610337 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-01-17

No results posted yet for this study

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

DRUG

Cethrin® (BA-210)

Intraoperative epidural administration during spinal decompression surgery

PROCEDURE

placebo

Spinal decompression surgery without administration of Cethrin® BA-210

Sponsors & Collaborators

  • BioAxone BioSciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00610337 on ClinicalTrials.gov