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Cethrin in Acute Cervical Spinal Cord Injury

NCT02053883 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2014-11-26

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Cethrin (BA-210)

High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.

DRUG

Placebo

Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.

Sponsors & Collaborators

  • BioAxone BioSciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-05-31

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Entities

Drugs

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 NCT02053883 on ClinicalTrials.gov