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Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

Primary Purpose

Acute Cervical Spinal Cord Injury

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cethrin® (BA-210)
placebo
Sponsored by
BioAxone BioSciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cervical Spinal Cord Injury

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability to understand the requirements of the study, provide informed consent, agree to the study restrictions, and agree to return for the required assessments
  2. Males or females, 18 through 62 years of age, inclusive
  3. AIS Grade A, complete injury with the ability to obtain accurate baseline assessment
  4. Motor neurological level of C5, C6, or C7
  5. Subjects with acute cervical SCI scheduled to receive decompression/stabilization surgery
  6. Must be willing and able to participate in study procedures and assessments
  7. Must be medically stable
  8. 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
  9. Must provide witnessed verbal authorization for use and disclosure of protected health information (PHI)

Exclusion Criteria:

  1. Subjects who have participated in a clinical trial involving investigational medications, devices or procedures within 30 days before administration of CTM
  2. Subjects who require the use of mechanical ventilation
  3. Females with a positive serum pregnancy test
  4. Females who are breastfeeding
  5. Preexisting SCI
  6. Subjects who are unable to receive study medication within 72 hours of injury
  7. Subjects with peripheral nerve injury, brachial plexus injury, or multifocal SCI
  8. Subjects with injuries that prevent a comprehensive ASIA assessment
  9. Complete spinal cord transection
  10. Acute SCI because of gun shot or knife wound
  11. Subjects who are mentally or medically unstable, or are otherwise unlikely to complete the trial in the judgment of the investigator
  12. Subjects who present with history of symptomatic cervical spondylotic myelopathy
  13. Subjects with moderate to severe traumatic brain injury with a Glasgow Coma Scale score of less than 14
  14. History of multiple sclerosis or other neuromuscular disorder
  15. History of an adverse reaction to a fibrin sealant or its human or bovine components
  16. Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease
  17. History of cancer (except for basal cell carcinoma)
  18. Hemophilia or other bleeding abnormality
  19. Ankylosing spondylitis
  20. Use of insulin therapy to control diabetes mellitus within 6 months of SCI
  21. Known immunodeficiency, including human immunodeficiency virus or use of immunosuppressive or cancer chemotherapeutic drugs
  22. Body mass index (BMI) of ≥40 kg/m2 at screening (Appendix B includes a table for height and weight to calculate BMI)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    5

    6

    Arm Description

    1mg Cethrin®

    3mg Cethrin®

    6mg Cethrin®

    12mg Cethrin®. Administration of this dose is dependent on data from lower doses.

    18mg Cethrin®. Administration of this dose is dependent on data from lower doses.

    Outcomes

    Primary Outcome Measures

    Mean change in ASIA motor score
    Death
    Serious Adverse Events

    Secondary Outcome Measures

    ASIA Impairment Scale (AIS) grade
    Total motor score, upper extremity motor score, and lower extremity motor score
    Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left)
    Change in motor score within the ZPP (right and left)
    Spinal cord independence measure (SCIM) total score, subscores and individual items
    Functional independence measure (FIM) total score, subscores and individual items
    Adverse events

    Full Information

    First Posted
    January 15, 2008
    Last Updated
    January 16, 2014
    Sponsor
    BioAxone BioSciences, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00610337
    Brief Title
    Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to a change of sponsor
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BioAxone BioSciences, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Cervical Spinal Cord Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    1mg Cethrin®
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    3mg Cethrin®
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    6mg Cethrin®
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    12mg Cethrin®. Administration of this dose is dependent on data from lower doses.
    Arm Title
    6
    Arm Type
    Experimental
    Arm Description
    18mg Cethrin®. Administration of this dose is dependent on data from lower doses.
    Intervention Type
    Drug
    Intervention Name(s)
    Cethrin® (BA-210)
    Other Intervention Name(s)
    Cethrin®
    Intervention Description
    Intraoperative epidural administration during spinal decompression surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    placebo
    Intervention Description
    Spinal decompression surgery without administration of Cethrin® BA-210
    Primary Outcome Measure Information:
    Title
    Mean change in ASIA motor score
    Time Frame
    week 26
    Title
    Death
    Time Frame
    12 months
    Title
    Serious Adverse Events
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    ASIA Impairment Scale (AIS) grade
    Time Frame
    Week 4, Week 8, Week 16, Week 26, and Week 52
    Title
    Total motor score, upper extremity motor score, and lower extremity motor score
    Time Frame
    Week 4, Week 8, Week 16, Week 26, and Week 52
    Title
    Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left)
    Time Frame
    Week 4, Week 8, Week 16, Week 26, and Week 52
    Title
    Change in motor score within the ZPP (right and left)
    Time Frame
    Week 4, Week 8, Week 16, Week 26, and Week 52
    Title
    Spinal cord independence measure (SCIM) total score, subscores and individual items
    Time Frame
    Week 4, Week 8, Week 16, Week 26, and Week 52
    Title
    Functional independence measure (FIM) total score, subscores and individual items
    Time Frame
    Week 4, Week 8, Week 16, Week 26, and Week 52
    Title
    Adverse events
    Time Frame
    12 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: 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 Subjects who are mentally or medically unstable, or are otherwise unlikely to complete the trial in the judgment of the investigator Subjects who present with history of symptomatic cervical spondylotic myelopathy Subjects with moderate to severe traumatic brain injury with a Glasgow Coma Scale score of less than 14 History of multiple sclerosis or other neuromuscular disorder History of an adverse reaction to a fibrin sealant or its human or bovine components Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease History of cancer (except for basal cell carcinoma) Hemophilia or other bleeding abnormality Ankylosing spondylitis Use of insulin therapy to control diabetes mellitus within 6 months of SCI Known immunodeficiency, including human immunodeficiency virus or use of immunosuppressive or cancer chemotherapeutic drugs Body mass index (BMI) of ≥40 kg/m2 at screening (Appendix B includes a table for height and weight to calculate BMI)

    12. IPD Sharing Statement

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    Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

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