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Cethrin in Acute Cervical Spinal Cord Injury

NCT ID: NCT02053883

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Keywords

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SCI spinal cord injury biologic drug rho paralysis paraplegia tetraplegia quadriplegia trauma central nervous system fibrin sealant neurosurgery cervical regeneration neurotrauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Fibrin sealant only.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Cethrin (BA-210) - Low Dose

Low dose of Cethrin in a fibrin sealant.

Group Type EXPERIMENTAL

Cethrin (BA-210)

Intervention Type DRUG

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

Cethrin (BA-210) - High Dose

High dose of Cethrin in a fibrin sealant.

Group Type EXPERIMENTAL

Cethrin (BA-210)

Intervention Type DRUG

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

Interventions

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Cethrin (BA-210)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAxone BioSciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BA-210-201

Identifier Type: -

Identifier Source: org_study_id