Cethrin in Acute Cervical Spinal Cord Injury

NCT02053883 | Withdrawn Phase 2

• 1 other identifier: BA-210-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery

  Baseline to 6 Months

Secondary Outcomes (7)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Fibrin sealant only.

Drug: Placebo

Cethrin (BA-210) - Low Dose

EXPERIMENTAL

Low dose of Cethrin in a fibrin sealant.

Drug: Cethrin (BA-210)

Cethrin (BA-210) - High Dose

EXPERIMENTAL

High dose of Cethrin in a fibrin sealant.

Drug: Cethrin (BA-210)

Interventions

Cethrin (BA-210) DRUG

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

Cethrin (BA-210) - High Dose; Cethrin (BA-210) - Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioAxone BioSciences, Inc.: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Night Blindness, Congenital Stationary, Autosomal Dominant 1; Paralysis; Paraplegia; Quadriplegia; Wounds and Injuries

Interventions

exoenzyme C3, Clostridium botulinum

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Last Updated: November 26, 2014

Record last verified: 2014-11