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A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Alseres Pharmaceuticals, Inc
(Formerly Boston Life Sciences)
Information provided by: Alseres Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00500812
  Purpose

This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a complete thoracic injury. Dose levels from 0.3 mg - 9 mg of Cethrin will be administered.


Condition Intervention Phase
Spinal Cord Injury
Drug: BA-210
Phase I
Phase II

MedlinePlus related topics:   Spinal Cord Injuries   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase I/IIa Dose-Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BA-210 and the Neurological Status of Patients Following Administration of a Single Extradural Application of Cethrin During Surgery for Acute Thoracic and Cervical Spinal Cord Injury

Further study details as provided by Alseres Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The primary goal of this study is to determine the safety and tolerability of BA 210 when administered in conjunction with fibrin sealant to the dura mater of the spinal cord. [ Time Frame: Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy by AIS [ Time Frame: Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   February 2005
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: BA-210
    0.3, 1, 6, 6 or 9 mg of BA-210
  Eligibility
Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Patients will be enrolled in this study only if they meet all of the following criteria:

  • Informed Consent Form signed by the patient or patient's legal representative.
  • Male or female, aged 16-70 years, inclusive.
  • For Group 1, patients with acute thoracic (T2-T12) spinal cord injury; for Group 2, patients with acute cervical (C4-T1) spinal cord injury. The site of surgery should be able to accommodate a minimum volume of 2 mL of fibrin sealant.
  • Scheduled to undergo spinal decompression surgery or other interventional spinal surgery (e.g., fixation) within 7 days of injury.
  • ASIA Impairment Scale grade of A (complete, no motor or sensory function present in the sacral segment) as assessed within 12 hours before surgery.
  • Able to communicate effectively to obtain informed consent and to ensure neurological examination.

Exclusion Criteria:

Patients will not be enrolled in this study if they meet one of the following criteria:

  • Use of any experimental drug, or participation in any clinical trial, within 30 days prior to surgery.
  • History of adverse reaction to fibrin sealant.
  • History of hypersensitivity to bovine products.
  • Any medical condition that may interfere with the ASIA assessments.
  • Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease or malignancy.
  • Hemophilia or other bleeding abnormality as defined by:

    • Platelet level lower than 100 X 109/L
    • Activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal
    • Baseline hematocrit lower than 0.25
  • Gunshot wound as the presenting injury, or any evidence of transecting injury to the spinal cord (e.g., by stab wound).
  • Cognitive impairment which may preclude accurate neurological assessments (e.g. traumatic head injury with GCS of less than or equal to 14).
  • Ankylosing Spondylitis.
  • Diabetes mellitus requiring insulin therapy.
  • Known immunodeficiency, including Acquired Immune Deficiency Syndrome or use of immunosuppressive or cancer chemotherapeutic drugs.
  • Pregnancy or breastfeeding during the study. A serum pregnancy test will be performed at Screening for female patients of childbearing potential. In addition, patients who are considered likely to be pregnant may be excluded at th Investigator's discretion.
  • Any condition or situation likely to cause the patient to be unable or unwilling to participate in study procedures or participate in all scheduled study assessments, including follow up through Month 6.
  • Any condition likely to result in the patient's death within the next 6 Months.
  • Any other condition that, in the opinion of the Investigator, would preclude the patient's participation in the study.
  • Previous participation in this study.
  • Use of intravenous heparin in previous 48 hours, thrombolytics and/or aspirin containing products in the previous 10 days.
  • Non-traumatic causes of spinal cord injury (e.g. transverse myelitis, acute disc herniation, etc…).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500812

Locations
United States, Arizona
St. Joseph's Hospital & Medical Center    
      Phoenix, Arizona, United States, 85013
United States, Ohio
University of Cincinnati Mayfield Clinic and Spine Institute    
      Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Thomas Jefferson University Hospital    
      Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Univ.of Virginia Health System    
      Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Harborview Medical Center    
      Seattle, Washington, United States, 98104
Canada, Ontario
Toronto Western Hospital    
      Toronto, Ontario, Canada, M5T2S8
Sunnybrooke Health Sciences Centre    
      Toronto, Ontario, Canada, M4N3M5
Canada, Quebec
Hopital du Sacre-Coeur de Montreal    
      Montreal, Quebec, Canada, H4J1C5

Sponsors and Collaborators
Alseres Pharmaceuticals, Inc
(Formerly Boston Life Sciences)

Investigators
Principal Investigator:     Michael J. Fehlings, MD, PhD, FRCSC, FACS     Univestity Health Network, Toronto Western    
  More Information


Sponsor  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Alseres Pharmaceuticals ( Susan Flint, Senior Vice President, Drug Development )
Study ID Numbers:   BA-210-101
First Received:   July 11, 2007
Last Updated:   January 3, 2008
ClinicalTrials.gov Identifier:   NCT00500812
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Alseres Pharmaceuticals, Inc:
therapeutic  
therapeutique  
therapy  
motor  
sensory  
neurotherapy  
Bioaxone  
TRAUMA  
INJURY  
SPINAL  
THORACIC  
CERVICAL  
PARALYSIS  
PARAPLEGIA  
TETRAPLEGIA  
ACUTE
SURGERY
NEUROLOGY
NEURO
NEUROSURGERY
RESEARCH
NEURONS
NERVES
SCI
CORD
VERTEBRA
DECOMPRESSION
FIXATION
FUSION
REHABILITATION

Study placed in the following topic categories:
Paralysis
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Paraplegia
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Quadriplegia

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 03, 2008




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