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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500812
• Other study ID #: BA-210-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2007
• Last updated: March 9, 2015
• Start date: February 2005
• Est. completion date: February 2009

Study information

• Verified date: May 2012
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00104221

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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…).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Cethrin
(BA-210)

Locations

Country	Name	City	State
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Sunnybrooke Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
United States	Univ.of Virginia Health System	Charlottesville	Virginia
United States	University of Cincinnati Mayfield Clinic and Spine Institute	Cincinnati	Ohio
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	University of Washington Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Fehlings MG, Theodore N, Harrop J, Maurais G, Kuntz C, Shaffrey CI, Kwon BK, Chapman J, Yee A, Tighe A, McKerracher L. A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury. J Neurotrauma. 2011 May;28(5):787-96. — View Citation

McKerracher L, Anderson KD. Analysis of recruitment and outcomes in the phase I/IIa Cethrin clinical trial for acute spinal cord injury. J Neurotrauma. 2013 Nov 1;30(21):1795-804. doi: 10.1089/neu.2013.2909. Epub 2013 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months	Yes
Secondary	Efficacy by AIS		Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months	No

External Links

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•   Sponsor