Cethrin in Acute Cervical Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02053883
• Other study ID #: BA-210-201
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 31, 2014
• Last updated: November 25, 2014
• Start date: July 2015

Study information

• Verified date: November 2014
• Source: BioAxone BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

• Males or females, ages 18-62, inclusive

• Acute cervical spinal cord injury at a neurological level of C4-C6

• AIS Grade A or B

• Scheduled to undergo decompression/stabilization surgery within five days of injury

• Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits

Exclusion Criteria:

• Participation in any other clinical trial for acute SCI, including previous Cethrin trial

• Inability to receive study medication within five days of injury

• Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI

• Significant hemorrhage on MRI/CT scan

• Females who are breastfeeding or have a positive serum pregnancy test

• Body mass index (BMI) of = 35 kg/m2 at screening

• History of an adverse reaction to a fibrin sealant or its human or bovine components

• Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours

• Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)

• Unconsciousness or other impairment that precludes reliable ASIA examination

• Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs

• Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Cethrin (BA-210)
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.
• Placebo
Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioAxone BioSciences, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery		Baseline to 6 Months	No
Secondary	ASIA Total Motor Score Recovery		Baseline to 6 Months	No
Secondary	ASIA Impairment Scale (AIS) Grade Recovery		Baseline to 6 Months	No
Secondary	Motor Neurological Level Recovery		Baseline to 6 Months	No
Secondary	ASIA Sensory Score Recovery		Baseline to 6 Months	No
Secondary	Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)		6 Months	No
Secondary	Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)		6 Months	No
Secondary	Incidence of Adverse Events		0-6 Months	Yes