Stopped: Compound recently partnered with another company for continued development.
0Started 2015-07
Plain-language 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.
Who can participate
Age range18 Years – 62 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immunodeficienc…
What they're measuring
1
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery