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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500812
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Cethrin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.3 mg
Subjects Receiving 0.3 mg Cethrin
 Drug: Cethrin
Other Name: (BA-210)
Experimental: 1 mg
Subjects receiving 1 mg Cethrin
 Drug: Cethrin
Other Name: (BA-210)
Experimental: 3 mg
Subjects receiving 3 mg Cethrin
 Drug: Cethrin
Other Name: (BA-210)
Experimental: 6 mg
Subjects receiving 6 mg Cethrin
 Drug: Cethrin
Other Name: (BA-210)
Experimental: 9 mg
Subjects receiving 9 mg Cethrin
 Drug: Cethrin
Other Name: (BA-210)


Outcome Measures
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Primary Outcome Measures :
  1. The primary goal of this study is to determine the safety and tolerability of Cethrin 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 ]

Secondary Outcome Measures :
  1. Efficacy by AIS [ Time Frame: Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500812


Locations
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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
Sunnybrooke Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
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Principal Investigator: Michael J. Fehlings, MD, PhD, FRCSC, FACS Univestity Health Network, Toronto Western
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00500812    
Obsolete Identifiers: NCT00104221
Other Study ID Numbers: BA-210-101
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: May 2012
Keywords provided by Vertex Pharmaceuticals Incorporated:
spinal cord injury
biologic drug
transport sequence
rho
paralysis
paraplegia
 tetraplegia
quadraplegia
trauma
nervous system
fibrin sealant
neurosurgery
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System