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Clinical Trials

We believe it is important to participate in clinical trials as often as possible. Please check this page frequently to see what new studies are currently running and if you have a patient that might benefit by taking part.

Epilepsy

Epilepsy is defined as a brain disorder characterized by spontaneously occurring seizures and is the most common neurologic disorder that affects pet dogs. Seizures represent uncontrolled brain cell electrical activity leading to convulsions. Seizures can be focal (e.g., one body part), generalized (entire body involved), or a combination (i.e., focal leading to generalized).

Epilepsy is estimated to affect from 1-5% of the entire canine population. A diagnosis of exclusion, epilepsy is diagnosed based on characteristic clinical features, often supplemented with normal brain MRI and cerebrospinal fluid (CSF) results.

The first line of treatment for epilepsy in dogs is, as in humans, oral drugs. Unfortunately, as in humans, antiepileptic drugs (AEDs) can be difficult to manage adequately in a realistic daily schedule, they can also have side effects (sedation, incoordination, liver failure) and may be ineffective.

About 25-30% of epileptic dogs, as in humans, are considered resistant to drug therapy and are defined by the term “refractory epilepsy”. One subset of refractory epilepsy is a condition called temporal lobe epilepsy (TLE). In TLE cases, a part of the brain called the hippocampus and its associated cerebral neighbor, the temporal lobe, are abnormally small on one side vs the other. In TLE, the seizures originate from the abnormal hippocampus/temporal lobe region.

Gene Therapy

Gene therapy is the use of DNA which is introduced into certain cells of the patient, either to compensate for abnormal/defective genes or to produce an increased amount of a beneficial protein.

For the DNA to enter a cell it needs a carrier called a vector. Certain viruses are often used as vectors because they can
deliver the new gene by entering the target cells safely. The viruses are modified so they cannot cause disease in the patient and are merely acting as a mere transportation system.

The vector with the new genes can be injected directly into a specific tissue in the body, where it is taken up by individual cells (in this case neurons in the brain). When the new genes are inside the cell nucleus, they utilize the cell’s normal protein production system to express the proteins they code for.

Project and Study

In the LIVS epilepsy project, two new genes are inserted into an adeno-associated virus (AAV) vector, which is used to introduce the new genes into the epileptic dog’s brain cells. This procedure has been shown to be safe in dogs.

To qualify for the study, a dog must be diagnosed with refractory idiopathic epilepsy. Dogs enrolled in the study will receive an MRI of the brain if they haven’t had one already, and measurements of specific brain regions (mainly the hippocampus) will be made to ascertain if there is a difference in size between left and right sides of the brain (i.e., consistent with TLE).

Those dogs with an obvious difference in size between the right and left hippocampus will be eligible for the study. Treatment consists of injecting an AAV vector designed to introduce genes that will help decrease seizure activity directly into the hippocampus, while the patient is under anesthesia. Administration of these genes demonstrated anticonvulsant properties in experimental models studying TLE and caused no adverse effects in healthy dogs.

Dogs will be included based on their refractory epileptic status and on review of a previous MRI, if available.

Dogs will be monitored over an initial period of 8-12 weeks to determine their seizure frequency while on regular treatment (oral drugs). They will receive a detailed physical and neurological examination at each appointment, along with regular bloodwork. Dogs who qualify will then receive an MRI examination of the brain to allow for determination of the appropriate injection site. Patients are expected to be sent home within 2-3 days after the procedure (they will be monitored in the hospital initially for post-operative recovery).

Dogs who receive treatment will then be monitored for an additional 12 weeks, and the frequency of the seizures reported at home will be compared to the frequency observed during the initial observation period. It is hoped that treatment will decrease the seizure frequency and duration during the second period of monitoring for the dogs treated.

LIVS Contacts

LIVS is very excited to have the opportunity to offer such innovative treatment to its patients suffering from refractory epilepsy. Uncontrolled seizures pose a substantial health threat to the patient and can cause extreme stress to the family of an affected dog. To bring this to reality and make it a success, LIVS has dedicated a specific team to this project, including neurologists, neurosurgeons and dedicated client service representatives. If you believe your own dog or one belonging to one of your patients would qualify for this study and you would like to obtain more information, please feel free to contact Kristy Farruggia, Debbie Mora, Marissa O’Donnell at epilepsystudy@www.livs.org. For any medical questions/inquiries please call 516-501-1700 and ask to speak with either Dr. Ann Bilderback, Dr. Curtis Dewey, Dr. Dominic J. Marino or Dr. Patrick Roynard.

Ann Bilderback

DVM, DACVIM (Neurology)

Curtis Dewey

DVM, MS, CTCVMP, DACVS, DACVIM (Neurology/Neurosurgery)

Dominic J. Marino

DVM, DACVS, DACCT, CCRP (Neurosurgery)

Patrick Roynard

DVM, MRCVS, DACVIM (Neurology/Neurosurgery)

Debbie Mora

Client Liaison

Kristy Farruggia

Client Liaison

Marissa O'Donnell

Client Liaison