Cethrin in Acute Cervical Spinal Cord Injury

BioAxone BioSciences

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Spinal Cord Injury

Treatments: Drug: Cethrin (BA-210); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02053883

BA-210-201

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 62 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Fibrin sealant only.

Treatment:

Drug: Placebo

Cethrin (BA-210) - Low Dose

Experimental group

Description:

Low dose of Cethrin in a fibrin sealant.

Treatment:

Drug: Cethrin (BA-210)

Cethrin (BA-210) - High Dose

Experimental group

Description:

High dose of Cethrin in a fibrin sealant.

Treatment:

Drug: Cethrin (BA-210)