Clinical trial NCT02053883: Cethrin in Acute Cervical Spinal Cord Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
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
Lead sponsor: BioAxone BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
timeFrame: Baseline to 6 Months
Secondary outcomes:
measure: ASIA Total Motor Score Recovery
timeFrame: Baseline to 6 Months
measure: ASIA Impairment Scale (AIS) Grade Recovery
timeFrame: Baseline to 6 Months
measure: Motor Neurological Level Recovery
timeFrame: Baseline to 6 Months
measure: ASIA Sensory Score Recovery
timeFrame: Baseline to 6 Months
measure: Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
timeFrame: 6 Months
measure: Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: 6 Months
measure: Incidence of Adverse Events
timeFrame: 0-6 Months
Other outcomes:
Locations:
Study officials:
References: