Back to resultsCethrin in Acute Cervical Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cethrin (BA-210)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring SCI, spinal cord injury, biologic drug, rho, paralysis, paraplegia, tetraplegia, quadriplegia, trauma, central nervous system, fibrin sealant, neurosurgery, cervical, regeneration, neurotrauma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Cethrin (BA-210) - Low Dose
Cethrin (BA-210) - High Dose
Arm Description
Fibrin sealant only.
Low dose of Cethrin in a fibrin sealant.
High dose of Cethrin in a fibrin sealant.
Outcomes
Primary Outcome Measures
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
Secondary Outcome Measures
ASIA Total Motor Score Recovery
ASIA Impairment Scale (AIS) Grade Recovery
Motor Neurological Level Recovery
ASIA Sensory Score Recovery
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Incidence of Adverse Events
Full Information
NCT ID
NCT02053883
First Posted
January 31, 2014
Last Updated
November 25, 2014
Sponsor
BioAxone BioSciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02053883
Brief Title
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
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Compound recently partnered with another company for continued development.
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioAxone BioSciences, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Fibrin sealant only.
Arm Title
Cethrin (BA-210) - Low Dose
Arm Type
Experimental
Arm Description
Low dose of Cethrin in a fibrin sealant.
Arm Title
Cethrin (BA-210) - High Dose
Arm Type
Experimental
Arm Description
High dose of Cethrin in a fibrin sealant.
Intervention Type
Drug
Intervention Name(s)
Cethrin (BA-210)
Intervention Description
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.
Primary Outcome Measure Information:
Title
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
Time Frame
Baseline to 6 Months
Secondary Outcome Measure Information:
Title
ASIA Total Motor Score Recovery
Time Frame
Baseline to 6 Months
Title
ASIA Impairment Scale (AIS) Grade Recovery
Time Frame
Baseline to 6 Months
Title
Motor Neurological Level Recovery
Time Frame
Baseline to 6 Months
Title
ASIA Sensory Score Recovery
Time Frame
Baseline to 6 Months
Title
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
Time Frame
6 Months
Title
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time Frame
6 Months
Title
Incidence of Adverse Events
Time Frame
0-6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Cethrin in Acute Cervical Spinal Cord Injury
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