Cethrin in Acute Cervical Spinal Cord Injury

Study Overview
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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.

Official Title
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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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: Cethrin (BA-210)
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, spinal cord injury, biologic drug, rho, paralysis, paraplegia, tetraplegia, quadriplegia, SCI, central nervous system, fibrin sealant, neurosurgery, cervical, regeneration, neurotrauma