Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury - Full Text View

Sponsor:	Alseres Pharmaceuticals, Inc
Information provided by:	Alseres Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00610337

Purpose

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.

Condition	Intervention	Phase
Acute Cervical Spinal Cord Injury	Drug: Cethrin® (BA-210) Procedure: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIb, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Safety and Efficacy of Intraoperative Epidural Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Alseres Pharmaceuticals, Inc:

Primary Outcome Measures:

Mean change in ASIA motor score [ Time Frame: week 26 ] [ Designated as safety issue: No ]
Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ASIA Impairment Scale (AIS) grade [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
Total motor score, upper extremity motor score, and lower extremity motor score [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left) [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
Change in motor score within the ZPP (right and left) [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
Spinal cord independence measure (SCIM) total score, subscores and individual items [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
Functional independence measure (FIM) total score, subscores and individual items [ Time Frame: Week 4, Week 8, Week 16, Week 26, and Week 52 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	October 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Procedure: placebo Spinal decompression surgery without administration of Cethrin® BA-210
2: Experimental 1mg Cethrin®	Drug: Cethrin® (BA-210) Intraoperative epidural administration during spinal decompression surgery
3: Experimental 3mg Cethrin®	Drug: Cethrin® (BA-210) Intraoperative epidural administration during spinal decompression surgery
4: Experimental 6mg Cethrin®	Drug: Cethrin® (BA-210) Intraoperative epidural administration during spinal decompression surgery
5: Experimental 12mg Cethrin®. Administration of this dose is dependent on data from lower doses.	Drug: Cethrin® (BA-210) Intraoperative epidural administration during spinal decompression surgery
6: Experimental 18mg Cethrin®. Administration of this dose is dependent on data from lower doses.	Drug: Cethrin® (BA-210) Intraoperative epidural administration during spinal decompression surgery

Eligibility

Ages Eligible for Study:	18 Years to 62 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease
History of cancer (except for basal cell carcinoma)
Hemophilia or other bleeding abnormality
Ankylosing spondylitis
Use of insulin therapy to control diabetes mellitus within 6 months of SCI
Known immunodeficiency, including human immunodeficiency virus or use of immunosuppressive or cancer chemotherapeutic drugs
Body mass index (BMI) of ≥40 kg/m2 at screening (Appendix B includes a table for height and weight to calculate BMI)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610337

Contacts

Contact: Susan Flint, MS, RAC, CCRA, CCRP

508-497-2360 ext 242

sflint@alseres.com

Sponsors and Collaborators

Alseres Pharmaceuticals, Inc

Investigators

Principal Investigator:

Michael G. Fehlings, M.D., Ph.D.

Toronto Western Hospital

More Information

No publications provided

Responsible Party:	Alseres Pharmaceuticals, Inc. ( Susan M. Flint, MS, RAC, CCRA, CCRP Senior VP Drug Development )
Study ID Numbers:	ALSE-C-01
Study First Received:	January 15, 2008
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00610337 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on November 20, 2009