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 range
18 Years – 62 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery