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Cethrin in Acute Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02053883
Recruitment Status : Withdrawn (Compound recently partnered with another company for continued development.)
First Posted : February 4, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
BioAxone BioSciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Cethrin (BA-210) Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Fibrin sealant only.
Drug: Placebo
Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.

Experimental: Cethrin (BA-210) - Low Dose
Low dose of Cethrin in a fibrin sealant.
Drug: Cethrin (BA-210)
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.

Experimental: Cethrin (BA-210) - High Dose
High dose of Cethrin in a fibrin sealant.
Drug: Cethrin (BA-210)
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.




Primary Outcome Measures :
  1. American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery [ Time Frame: Baseline to 6 Months ]

Secondary Outcome Measures :
  1. ASIA Total Motor Score Recovery [ Time Frame: Baseline to 6 Months ]
  2. ASIA Impairment Scale (AIS) Grade Recovery [ Time Frame: Baseline to 6 Months ]
  3. Motor Neurological Level Recovery [ Time Frame: Baseline to 6 Months ]
  4. ASIA Sensory Score Recovery [ Time Frame: Baseline to 6 Months ]
  5. Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore) [ Time Frame: 6 Months ]
  6. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [ Time Frame: 6 Months ]
  7. Incidence of Adverse Events [ Time Frame: 0-6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: BioAxone BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT02053883    
Other Study ID Numbers: BA-210-201
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014
Keywords provided by BioAxone BioSciences, Inc.:
spinal cord injury
trauma
SCI
biologic drug
rho
paralysis
paraplegia
tetraplegia
quadriplegia
central nervous system
fibrin sealant
neurosurgery
cervical
regeneration
neurotrauma
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Fibrin Tissue Adhesive
Hemostatics
Coagulants