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

NCT00500812 | Completed Phase 1 DMC

• 1 other identifier: BA-210-101
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 8

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.

Conditions

Spinal Cord Injury

Keywords

biologic drug; transport sequence; rho; spinal cord injury; paralysis; paraplegia; tetraplegia; quadraplegia; trauma; nervous system; fibrin sealant; neurosurgery

Outcome Measures

Primary Outcomes (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.

  Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months

Secondary Outcomes (1)

• Efficacy by AIS

  Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months

Study Arms (5)

0.3 mg

EXPERIMENTAL

Subjects Receiving 0.3 mg Cethrin

Drug: Cethrin

1 mg

EXPERIMENTAL

Subjects receiving 1 mg Cethrin

Drug: Cethrin

3 mg

EXPERIMENTAL

Subjects receiving 3 mg Cethrin

Drug: Cethrin

6 mg

EXPERIMENTAL

Subjects receiving 6 mg Cethrin

Drug: Cethrin

9 mg

EXPERIMENTAL

Subjects receiving 9 mg Cethrin

Drug: Cethrin

Interventions

Cethrin DRUG

Also known as: (BA-210)

0.3 mg; 1 mg; 3 mg; 6 mg; 9 mg

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (8)

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

University of Cincinnati Mayfield Clinic and Spine Institute

Cincinnati, Ohio, 45267, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Univ.of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Sunnybrooke Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 23844986 RESULT

• 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. doi: 10.1089/neu.2011.1765.

  PMID: 21381984 RESULT

Related Links

• Sponsor
• Publication

MeSH Terms

Conditions

Spinal Cord Injuries; Night Blindness, Congenital Stationary, Autosomal Dominant 1; Paralysis; Paraplegia; Quadriplegia; Wounds and Injuries; Neurologic Manifestations

Interventions

exoenzyme C3, Clostridium botulinum

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J. Fehlings, MD, PhD, FRCSC, FACS

  Univestity Health Network, Toronto Western

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 13, 2007
• Study Start: February 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: April 14, 2016

Record last verified: 2012-05

Locations

CA (3); US (5)