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Investigational Treatments and Drug Trials for Epilepsy

Investigational Treatments and Drug Trials for Epilepsy

Seizures can usually be brought under control with antiepileptic medication. However in one third of patients, seizures persist despite trials of numerous drugs. For those individuals, we consider alternative approaches, including neurosurgical removal of the seizure source from the brain, the ketogenic diet, and hormone therapy.

For some patients, surgical removal of the source of their seizures is not possible, because this area might be in a critically important part of the brain and the risks of surgery would be too great; or there might be multiple seizures sources. For these people, experimental implanted electrical brain simulators may prove helpful. At the Weill Cornell Epilepsy Center, we are conducting investigational trials of two methods of brain stimulation for epilepsy: stimulation of the anterior nucleus of the thalamus, and the responsive brain stimulator.

Investigational Treatments

Responsive Brain Stimulation for Epilepsy

Responsive brain stimulation functions by delivering a counter-shock to the seizure source in the brain at the moment a seizure starts. This is thought to interrupt the seizure and stop it before it spreads and becomes severe.

The responsive brain stimulator employs a small battery-operated computer that is surgically implanted in the skull to detect the abnormal brain electrical activity that represents a seizure. This tiny computer is connected with thin wires to an electrode implanted in the brain at the seizure source. When the device detects a seizure, it immediately sends a counter-shock to block it.

Patients with brain stimulators still take antiepileptic medications. However, rather than coming to their doctor for medication prescription changes, patients in the responsive brain stimulator study come to get their stimulator settings reprogrammed with a magnetic device that the treating doctor uses to send information through the skin.

The Weill Cornell Epilepsy Center is currently conducting the following trial on neurostimulation:

V-COMPAS: This post-market study is designed to follow the clinical course and outcomes for patients with seizures that are difficult to manage and treated with VNS Therapy as a supplement to their primary treatment. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients who have failed initial trials of anti-epileptic drug (AED) therapy.

Investigational Drug Trials

Before a medication is available by prescription, it is extensively tested in the laboratory for safety, effectiveness, and effects on reproduction. Later, when the medication is shown to be safe, it is tested for long-term safety and effectiveness on patients. These tests are called investigational drug trials.

The Weill Cornell Epilepsy Center of NewYork-Presbyterian Hospital's FDA-approved investigational drug trials have made new, investigational antiepileptic medications available to our patients. Through clinical trials, we have had extensive experience with newer agents such as gabapentin, topiramate, tiagabine, lamotrigine, zonisamide and levetiracetam.

All investigational trials are approved by the FDA, which closely supervises the study along with the epilepsy center staff and the company providing the medication. Patients enrolled in an investigational study receive very close follow-up care and careful medical supervision to assure that no problems arise during the trial. Most investigational drug trials provide the medication under study at no cost, as well as free comprehensive care (laboratory tests and studies EEG and MRI in some cases and doctors' visits) and travel compensation for patients.

The Weill Cornell Epilepsy Center is currently conducting the following investigational drug trials:

ESLICARBAZEPINE: The purpose of this study is to determine the efficacy and safety of eslicarbazepine acetate as an aid to a primary treatment for partial seizures that are difficult to manage.

LACOSAMIDE: The objective of trial is to demonstrate the efficacy and safety of conversion to treatment with lacosamide as the single drug in patients with partial-onset seizures who are no longer on one to two other marketed drugs.

LEXAPRO: The primary objective will be to pilot the use of escitalopram for the treatment of major depression in patients with epilepsy. The secondary objectives will be to determine the strength of the relationship between the use of this medication and scales of depressive symptoms, physical symptoms, psychosocial function and quality of life, and to evaluate safety in the population of patients with epilepsy.

For more information on new epilepsy treatments available at New-York Presbyterian Hospital/Weill Cornell Medical Center, please contact the Weill Cornell Epilepsy Center at (212) 746 5519.

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New York-Presbyterian. The University Hospitals of Columbia and Cornell