Clinical Trial of ASO Treatment in DM Affected Dogs
Contact Dr. Coates Email: firstname.lastname@example.org Phone: 573-882-7821
The purpose of this study is to evaluate the efficacy of a promising new drug as a treatment for DM with hopes to slow disease progression. Dogs will be administered an antisense oligonucleotide (ASO) that will repress the production of the mutant protein, superoxide dismutase 1 (SOD1). The ASO has been tested in a preclinical setting for safety in dogs. The drug will be injected into the spinal fluid at the low lumbar region of the spinal cord. The study will be randomized and double blinded; meaning the investigator and the pet owner will not know whether the dog receives the drug. Eight dogs will receive the drug and 4 dogs will receive the vehicle. Based on the randomization design, your dog has a 67% chance of receiving the therapy.
We will monitor clinical disease progression and evaluate cerebrospinal fluid, brain MRI and a new electrodiagnostic technique, motor unit number estimate (MUNE). This technique has been used extensively on ALS patients in order to monitor and predict disease progression. We would like to use this same technique with brain MRI on DM-affected dogs for monitoring disease progression and to evaluate for efficacy of the therapeutic.
INCLUSION CRITERIA BELOW MUST BE MET TO BE CONSIDERED FOR STUDY
Boxers approximately 9 years of age or older at the time of initial examination
Diagnostic Testing (Performed by a board-certified veterinary neurologist: www.acvim.org)
No significant abnormalities on bloodwork, thoracic radiographs and abdominal ultrasound
Treatments and Follow-up Testing
THE CANDIDATE DOG MUST BE ABLE TO COME TO THE UNIVERSITY OF MISSOURI FOR BASELINE TESTING, EVERY THREE MONTHS THEREAFTER AND AT THE TIME OF EUTHANASIA. It is easiest if you are within driving distance but we can work with a board-certified neurologist to administer once a month injections into the spinal fluid.
June 5, 2015
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