Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

NCT00610337 | Withdrawn Phase 2 DMC

• 1 other identifier: ALSE-C-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury. This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®. This adaptive study has been designed to efficiently identify the safest and most effective dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack of effective treatments for SCI, an improvement in motor ability or activities of daily living in these subjects would be a great advancement in the treatment of SCI.

Conditions

Acute Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Mean change in ASIA motor score

  week 26

• Death

  12 months

• Serious Adverse Events

  12 months

Secondary Outcomes (7)

• ASIA Impairment Scale (AIS) grade

  Week 4, Week 8, Week 16, Week 26, and Week 52

• Total motor score, upper extremity motor score, and lower extremity motor score

  Week 4, Week 8, Week 16, Week 26, and Week 52

• Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left)

  Week 4, Week 8, Week 16, Week 26, and Week 52

• Change in motor score within the ZPP (right and left)

  Week 4, Week 8, Week 16, Week 26, and Week 52

• Spinal cord independence measure (SCIM) total score, subscores and individual items

  Week 4, Week 8, Week 16, Week 26, and Week 52

Study Arms (6)

1

PLACEBO COMPARATOR

Procedure: placebo

2

EXPERIMENTAL

1mg Cethrin®

Drug: Cethrin® (BA-210)

3

EXPERIMENTAL

3mg Cethrin®

Drug: Cethrin® (BA-210)

4

EXPERIMENTAL

6mg Cethrin®

Drug: Cethrin® (BA-210)

5

EXPERIMENTAL

12mg Cethrin®. Administration of this dose is dependent on data from lower doses.

Drug: Cethrin® (BA-210)

6

EXPERIMENTAL

18mg Cethrin®. Administration of this dose is dependent on data from lower doses.

Drug: Cethrin® (BA-210)

Interventions

Cethrin® (BA-210) DRUG

Intraoperative epidural administration during spinal decompression surgery

Also known as: Cethrin®

2; 3; 4; 5; 6

placebo PROCEDURE

Spinal decompression surgery without administration of Cethrin® BA-210

1

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to understand the requirements of the study, provide informed consent, agree to the study restrictions, and agree to return for the required assessments
• Males or females, 18 through 62 years of age, inclusive
• AIS Grade A, complete injury with the ability to obtain accurate baseline assessment
• Motor neurological level of C5, C6, or C7
• Subjects with acute cervical SCI scheduled to receive decompression/stabilization surgery
• Must be willing and able to participate in study procedures and assessments
• Must be medically stable
• If of childbearing potential, women must agree to either of the following for the duration of the 12-month trial: (a) abstinence, or (b) if sexually active, to use one of the following methods of birth control: barrier with spermicide, intrauterine device, birth control hormones, or surgical sterilization
• Must provide witnessed verbal authorization for use and disclosure of protected health information (PHI)

You may not qualify if:

• Subjects who have participated in a clinical trial involving investigational medications, devices or procedures within 30 days before administration of CTM
• Subjects who require the use of mechanical ventilation
• Females with a positive serum pregnancy test
• Females who are breastfeeding
• Preexisting SCI
• Subjects who are unable to receive study medication within 72 hours of injury
• Subjects with peripheral nerve injury, brachial plexus injury, or multifocal SCI
• Subjects with injuries that prevent a comprehensive ASIA assessment
• Complete spinal cord transection
• Acute SCI because of gun shot or knife wound
• Subjects who are mentally or medically unstable, or are otherwise unlikely to complete the trial in the judgment of the investigator
• Subjects who present with history of symptomatic cervical spondylotic myelopathy
• Subjects with moderate to severe traumatic brain injury with a Glasgow Coma Scale score of less than 14
• History of multiple sclerosis or other neuromuscular disorder
• History of an adverse reaction to a fibrin sealant or its human or bovine components

Sponsors & Collaborators

• BioAxone BioSciences, Inc.: lead

MeSH Terms

Interventions

exoenzyme C3, Clostridium botulinum

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: February 7, 2008
• Last Updated: January 17, 2014

Record last verified: 2010-02