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Spinal Cord InjuryPhase 1/2NCT00500812

A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries

A Phase 1/2 study testing Cethrin in people with Spinal Cord Injury, run by Vertex Pharmaceuticals Incorporated at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Cethrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
8 sitesin 2 countries
Study dates
Feb 2005to Feb 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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
  • Gunshot wound as the presenting injury, or any evidence of transecting injury to the spinal cord (e.g., by stab wound).
  • Cognitive impairment which may preclude accurate neurological assessments (e.g. traumatic head injury with GCS of less than or equal to 14).
  • Ankylosing Spondylitis.
  • Diabetes mellitus requiring insulin therapy.
  • Known immunodeficiency, including Acquired Immune Deficiency Syndrome or use of immunosuppressive or cancer chemotherapeutic drugs.
  • Pregnancy or breastfeeding during the study. A serum pregnancy test will be performed at Screening for female patients of childbearing potential. In addition, patients who are considered likely to be pregnant may be excluded at th Investigator's discretion.
  • Any condition or situation likely to cause the patient to be unable or unwilling to participate in study procedures or participate in all scheduled study assessments, including follow up through Month 6.
  • Any condition likely to result in the patient's death within the next 6 Months.
  • Any other condition that, in the opinion of the Investigator, would preclude the patient's participation in the study.
  • Previous participation in this study.
  • Use of intravenous heparin in previous 48 hours, thrombolytics and/or aspirin containing products in the previous 10 days.
  • Non-traumatic causes of spinal cord injury (e.g. transverse myelitis, acute disc herniation, etc…).

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States5 sites

  • Univ.of Virginia Health System

    Charlottesville, Virginia, 22908

  • University of Cincinnati Mayfield Clinic and Spine Institute

    Cincinnati, Ohio, 45267

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, 85013

  • University of Washington Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

Canada3 sites

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J1C5

  • Sunnybrooke Health Sciences Centre

    Toronto, Ontario, M4N3M5

  • Toronto Western Hospital

    Toronto, Ontario, M5T2S8

Other trials in Canada

About this study

Official title: 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

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.

Being tested
Cethrin
Keywords
biologic drug, transport sequence, rho, spinal cord injury, paralysis, paraplegia, tetraplegia, quadraplegia, trauma, nervous system, fibrin sealant, neurosurgery
Medical subject headings
Spinal Cord Injuries, Night Blindness, Congenital Stationary, Autosomal Dominant 1, Paralysis, Paraplegia, Quadriplegia, Wounds and Injuries, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CethrinDrug

    Also called (BA-210)

Study groups in NCT00500812
Study groupRoleWhat they receive
0.3 mgExperimentalSubjects Receiving 0.3 mg Cethrin
Receives: Drug: Cethrin
1 mgExperimentalSubjects receiving 1 mg Cethrin
Receives: Drug: Cethrin
3 mgExperimentalSubjects receiving 3 mg Cethrin
Receives: Drug: Cethrin
6 mgExperimentalSubjects receiving 6 mg Cethrin
Receives: Drug: Cethrin
9 mgExperimentalSubjects receiving 9 mg Cethrin
Receives: Drug: Cethrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months

Secondary outcomes (1)

  1. Efficacy by AIS

    Measured: Pre-study, 24-72 hrs, 6 weeks, 3, 6 & 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2007 (estimated)
  2. Study startFeb 2005
  3. Primary completionDec 2008
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00500812
Sponsor's protocol ID
BA-210-101
Status last verified
May 2012
First submitted
11 Jul 2007
Last updated
14 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • McKerracher L, Anderson KD. Analysis of recruitment and outcomes in the phase I/IIa Cethrin clinical trial for acute spinal cord injury. J Neurotrauma. 2013 Nov 1;30(21):1795-804. doi: 10.1089/neu.2013.2909. Epub 2013 Oct 1.

    PubMed 23844986

  • Fehlings MG, Theodore N, Harrop J, Maurais G, Kuntz C, Shaffrey CI, Kwon BK, Chapman J, Yee A, Tighe A, McKerracher L. A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury. J Neurotrauma. 2011 May;28(5):787-96. doi: 10.1089/neu.2011.1765.

    PubMed 21381984

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cethrin in people with Spinal Cord Injury, run by Vertex Pharmaceuticals Incorporated at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00500812, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.

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