Cethrin in Acute Cervical Spinal Cord Injury

November 25, 2014 updated by: BioAxone BioSciences, Inc.

A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females, ages 18-62, inclusive
  • Acute cervical spinal cord injury at a neurological level of C4-C6
  • AIS Grade A or B
  • Scheduled to undergo decompression/stabilization surgery within five days of injury
  • Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits

Exclusion Criteria:

  • Participation in any other clinical trial for acute SCI, including previous Cethrin trial
  • Inability to receive study medication within five days of injury
  • Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
  • Significant hemorrhage on MRI/CT scan
  • Females who are breastfeeding or have a positive serum pregnancy test
  • Body mass index (BMI) of ≥ 35 kg/m2 at screening
  • History of an adverse reaction to a fibrin sealant or its human or bovine components
  • Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours
  • Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)
  • Unconsciousness or other impairment that precludes reliable ASIA examination
  • Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
  • Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Fibrin sealant only.
Drug: Placebo
Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.
Experimental: Cethrin (BA-210) - Low Dose
Low dose of Cethrin in a fibrin sealant.
Drug: Cethrin (BA-210)
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.
Experimental: Cethrin (BA-210) - High Dose
High dose of Cethrin in a fibrin sealant.
Drug: Cethrin (BA-210)
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
Time Frame: Baseline to 6 Months
Baseline to 6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
ASIA Total Motor Score Recovery
Time Frame: Baseline to 6 Months
Baseline to 6 Months
ASIA Impairment Scale (AIS) Grade Recovery
Time Frame: Baseline to 6 Months
Baseline to 6 Months
Motor Neurological Level Recovery
Time Frame: Baseline to 6 Months
Baseline to 6 Months
ASIA Sensory Score Recovery
Time Frame: Baseline to 6 Months
Baseline to 6 Months
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
Time Frame: 6 Months
6 Months
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time Frame: 6 Months
6 Months
Incidence of Adverse Events
Time Frame: 0-6 Months
0-6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAxone BioSciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

February 1, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA-210-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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