Clinical Trials and Research Projects  
Vet Clinical Trials
VIN.com


Vet Clinical Trials

Search


Browse by category




Powered By VIN

 

Category: Dogs

Methylprednisolone Sodium Succinate and Polyethylene Glycol in Canine Spinal Cord Injury (Study Closed)
September 18, 2008 (published)
Natasha Olby

You do not have permission to view this document: [5933971]!

Study Start Date: 09/01/2007
Study End Date: 08/31/2011

Published study results can be found here.

Methylprednisolone Sodium Succinate and Polyethylene Glycol in Canine Spinal Cord Injury.

Intervertebral disc herniations are common in certain breeds of dog and can cause severe spinal cord injuries resulting in permanent paralysis. Herniated disc causes contusion and compression of the spinal cord and surgical decompression by removal of this disc material is a standard method of treatment. Adjunctive medical management of the contusive injury to the spinal cord is frequently advocated but the choice of drug is extremely controversial and reports of efficacy are anecdotal. A high dose regimen of methylprednisolone sodium succinate (MPSS) has been adopted by some clinicians based on evidence of minor benefit from human trials, while many others disagree with this approach.

More recently, a Phase I trial of polyethylene glycol (PEG) showed promise in dogs with acute disc herniations but efficacy has yet to be established. The aim of this multicenter, blinded clinical trial is to compare the functional outcome of dogs with acute disc herniations decompressed surgically when treated adjunctively with MPSS, PEG or placebo. Preliminary data on the recovery of surgically treated dogs was used for trial design to ensure adequate statistical power to detect clinically relevant improvement.

The results of this study will address the long-standing controversy over the medical treatment of acute canine spinal cord injury, and will represent the first objective data on the optimal medical therapy for this common and serious problem.

Study Design:
Prospective, Placebo-controlled, Randomized, Blinded

Sample Size:
180 dogs

Inclusion Criteria:

  • Acute thoracolumbar disc herniation
  • Age 2 and 10 years
  • Weight <20 kg
  • Paraplegia without pain sensation at time of presentation for <24 hours (they may exhibit signs of disc herniation for more than 24 hours).
  • Dogs have to be presented to one of the study participating centers – full details of the participating centers can be found here (bottom of page lists all current participating centers).

Exclusion Criteria:

  • Dogs that have received more than two doses of a non-steroidal drug or a corticosteroid within 24 hours of presentation
  • Dogs that exhibit evidence of other systemic diseases that may delay their recovery or contraindicate use of high doses of steroid

Study Controls:
Dogs will be randomized to receive steroid, PEG or placebo.

Study Endpoints:
Neurological evaluation 12 weeks post operatively.

Costs/Reimbursements:
Participants will receive the test drug free of charge and will be rechecked at 2,4,8 and 12 weeks after surgery free of charge.

You do not have permission to view this document: [5934094]!

Full Disclosure information:

  • The study is funded by a grant from Morris Animal Foundation.
  • The investigators do not have any conflict of interest.
  • The study will be published if results are negative.
  • The study will be reported on VIN.
  • The authors will acknowledge VIN if the study is published.


Have questions or feedback? Email us