Clinical Trials/NCT00500812

NCT00500812

Completed

Phase 1

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

Vertex Pharmaceuticals Incorporated8 sites in 2 countries48 target enrollmentFebruary 2005

ConditionsSpinal Cord Injury

InterventionsCethrin

DrugsCethrin

Overview

Phase: Phase 1
Intervention: Cethrin
Conditions: Spinal Cord Injury
Sponsor: Vertex Pharmaceuticals Incorporated
Enrollment: 48
Locations: 8
Primary Endpoint: 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.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

February 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vertex Pharmaceuticals Incorporated

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

1 mg

Subjects receiving 1 mg Cethrin

Intervention: Cethrin

0.3 mg

Subjects Receiving 0.3 mg Cethrin

Intervention: Cethrin

3 mg

Subjects receiving 3 mg Cethrin

Intervention: Cethrin

6 mg

Subjects receiving 6 mg Cethrin

Intervention: Cethrin

9 mg

Subjects receiving 9 mg Cethrin

Intervention: Cethrin

Outcomes

Primary Outcomes

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