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

This study has been terminated.
(Product no longer will be developed by Alseres.)
Sponsor:
Information provided by:
Alseres Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00610337
First received: January 15, 2008
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Cervical Spinal Cord Injury
 Drug: Cethrin® (BA-210)
Procedure: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alseres Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Mean change in ASIA motor score [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ASIA Impairment Scale (AIS) grade [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in motor score within the ZPP (right and left) [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
  • Spinal cord independence measure (SCIM) total score, subscores and individual items [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
  • Functional independence measure (FIM) total score, subscores and individual items [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Arms Assigned Interventions
Placebo Comparator: 1 Procedure: placebo
Spinal decompression surgery without administration of Cethrin® BA-210
Experimental: 2
1mg Cethrin®
 Drug: Cethrin® (BA-210)
Intraoperative epidural administration during spinal decompression surgery
Other Name: Cethrin®
Experimental: 3
3mg Cethrin®
 Drug: Cethrin® (BA-210)
Intraoperative epidural administration during spinal decompression surgery
Other Name: Cethrin®
Experimental: 4
6mg Cethrin®
 Drug: Cethrin® (BA-210)
Intraoperative epidural administration during spinal decompression surgery
Other Name: Cethrin®
Experimental: 5
12mg Cethrin®. Administration of this dose is dependent on data from lower doses.
 Drug: Cethrin® (BA-210)
Intraoperative epidural administration during spinal decompression surgery
Other Name: Cethrin®
Experimental: 6
18mg Cethrin®. Administration of this dose is dependent on data from lower doses.
 Drug: Cethrin® (BA-210)
Intraoperative epidural administration during spinal decompression surgery
Other Name: Cethrin®

  Eligibility

Ages Eligible for Study:   18 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Susan M. Flint, MS, RAC, CCRA, CCRP Senior VP Drug Development, Talaris Advisors LLC
ClinicalTrials.gov Identifier: NCT00610337     History of Changes
Other Study ID Numbers: ALSE-C-01
Study First Received: January 15, 2008
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013