Comparison of the safety, tolerability, and efficacy, of levetiracetam versus phenytoin when administered intravenously to an inpatient population at risk for seizures.

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Brief Lay Summary of the Project: This study concerns the safety and tolerability of the intravenous form of levetiracetam, when compared with standard available therapy. In the hospital setting, people at risk for seizures may not be able to take medication by mouth to prevent the seizures, and so may need to be given a medication to prevent seizures by another route, most often directly into the vein (intravenously). A given patient may respond to one seizure preventing medication, but not so readily to another, and such specific response cannot readily be predicted. Also, a particular patient may not be able to take a particular medication safely, because of side effects with that medication in the past, or because they are taking other medications which do not mix with it. It is best that ongoing regular tablet medication and any intravenous medication a patient is given to stop seizures from happening, be the same drug known to work for that person. So it would be best to have a range or choice of intravenous seizure preventing medications to cover different patients’ needs, like there is with tablets now. These intravenous medications would need to be tested against each other to see whether they are as safe as medications already being used for the same thing, also to make sure that they work as well as the other medications, and to see whether certain people would benefit more from some medications than others. Until very recently, there has been little choice in seizure preventing medication to give intravenously in Australia. The mainstays have been benzodiazepine medications (which are not generally used longterm for seizure prevention, and cause drowsiness); and phenytoin , which can be continued as a tablet. Phenytoin generally works well for preventing seizures, but may have side effects, which can be serious, and must be given carefully, at just the right dose and speed. Levetiracetam is a newer seizure prevention medication, which has been widely used in tablet form, which can now be given in another form directly into the bloodstream by injection or 'drip' into the vein. It is the only specific seizure preventing drug available for intravenous use in Australia apart from phenytoin. Given in tablet form, levetiracetam has been shown to be very good at preventing seizures, has few side effects which generally are mild, and does not seem to interact with other medications that patients might be taking. This study aims to assess whether the intravenous levetiracetam medication has less side effects than the intravenous phenytoin, while working just as well to prevent seizures. Little difference is expected in the ability of the two drugs to prevent seizures, as they are both known to be very effective. Patients in hospital who need intravenous seizure preventing medication will be given an effective medication, either phenytoin or levetiracetam, for as long as they need it. This would usually be followed by at least three months of treatment with the same medication by mouth. Side effects and seizure frequency, will be recorded at three intervals – three days after starting medication, on leaving hospital, and three months after leaving hospital. The patient's treating doctors will make all the medical decisions regarding the patient's care, even if that means a patient has to stop the study. The results will be statistically analysed to compare the results for the two medication. In this way, the project hopes to tell whether levetiracetam is as safe and effective as phenytoin, when given intravenously to these types of patients.

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