Cethrin in Acute Cervical Spinal Cord Injury

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• Status: Withdrawn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: Spinal Cord Injury
• Intervention / Treatment: Drug: Placebo; Drug: Cethrin (BA-210)

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Baseline to 6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioAxone BioSciences, Inc.

Study record dates

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: trauma; spinal cord injury; SCI; quadriplegia; central nervous system; neurosurgery; neurotrauma; regeneration; tetraplegia; cervical; fibrin sealant; paralysis; paraplegia; biologic drug; rho
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: BA-210-201