A Phase IIb, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Safety and Efficacy of Intraoperative Epidural Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
Overview
- Phase
- Phase 2
- Intervention
- placebo
- Conditions
- Acute Cervical Spinal Cord Injury
- Sponsor
- BioAxone BioSciences, Inc.
- Primary Endpoint
- Death
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury.
This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®. This adaptive study has been designed to efficiently identify the safest and most effective dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack of effective treatments for SCI, an improvement in motor ability or activities of daily living in these subjects would be a great advancement in the treatment of SCI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand the requirements of the study, provide informed consent, agree to the study restrictions, and agree to return for the required assessments
- •Males or females, 18 through 62 years of age, inclusive
- •AIS Grade A, complete injury with the ability to obtain accurate baseline assessment
- •Motor neurological level of C5, C6, or C7
- •Subjects with acute cervical SCI scheduled to receive decompression/stabilization surgery
- •Must be willing and able to participate in study procedures and assessments
- •Must be medically stable
- •If of childbearing potential, women must agree to either of the following for the duration of the 12-month trial: (a) abstinence, or (b) if sexually active, to use one of the following methods of birth control: barrier with spermicide, intrauterine device, birth control hormones, or surgical sterilization
- •Must provide witnessed verbal authorization for use and disclosure of protected health information (PHI)
Exclusion Criteria
- •Subjects who have participated in a clinical trial involving investigational medications, devices or procedures within 30 days before administration of CTM
- •Subjects who require the use of mechanical ventilation
- •Females with a positive serum pregnancy test
- •Females who are breastfeeding
- •Preexisting SCI
- •Subjects who are unable to receive study medication within 72 hours of injury
- •Subjects with peripheral nerve injury, brachial plexus injury, or multifocal SCI
- •Subjects with injuries that prevent a comprehensive ASIA assessment
- •Complete spinal cord transection
- •Acute SCI because of gun shot or knife wound
Arms & Interventions
1
Intervention: placebo
2
1mg Cethrin®
Intervention: Cethrin® (BA-210)
3
3mg Cethrin®
Intervention: Cethrin® (BA-210)
4
6mg Cethrin®
Intervention: Cethrin® (BA-210)
5
12mg Cethrin®. Administration of this dose is dependent on data from lower doses.
Intervention: Cethrin® (BA-210)
6
18mg Cethrin®. Administration of this dose is dependent on data from lower doses.
Intervention: Cethrin® (BA-210)
Outcomes
Primary Outcomes
Death
Time Frame: 12 months
Serious Adverse Events
Time Frame: 12 months
Mean change in ASIA motor score
Time Frame: week 26
Secondary Outcomes
- ASIA Impairment Scale (AIS) grade(Week 4, Week 8, Week 16, Week 26, and Week 52)
- Total motor score, upper extremity motor score, and lower extremity motor score(Week 4, Week 8, Week 16, Week 26, and Week 52)
- Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left)(Week 4, Week 8, Week 16, Week 26, and Week 52)
- Change in motor score within the ZPP (right and left)(Week 4, Week 8, Week 16, Week 26, and Week 52)
- Spinal cord independence measure (SCIM) total score, subscores and individual items(Week 4, Week 8, Week 16, Week 26, and Week 52)
- Functional independence measure (FIM) total score, subscores and individual items(Week 4, Week 8, Week 16, Week 26, and Week 52)
- Adverse events(12 months)