Cethrin in Acute Cervical Spinal Cord Injury

Phase 2

Withdrawn

• Conditions: Spinal Cord Injury
• Interventions: Drug: Cethrin (BA-210); Drug: Placebo

• Registration Number: NCT02053883
• Lead Sponsor: BioAxone BioSciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-01
• Study First Posted: 2014-02-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26
• Study Start: 2015-07
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cethrin (BA-210) - High Dose	Cethrin (BA-210)	High dose of Cethrin in a fibrin sealant.
Placebo	Placebo	Fibrin sealant only.
Cethrin (BA-210) - Low Dose	Cethrin (BA-210)	Low dose of Cethrin in a fibrin sealant.

Primary Outcome Measures

Name	Time	Method
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery	Baseline to 6 Months

Secondary Outcome Measures

Name	Time	Method
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