This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. HYPOTHESIS(ES): Photosensitivity offers a useful model for acute antiepileptic drug studies in man. The technique of using the photosensitive range as an index for antiepileptic action has been proven to be effective w/a number of well-known antiepileptic drugs. In addition, photosensitivity range appears to be a useful tool for preliminary investigation of new potential antiepileptic drugs. Apart from information concerning the efficacy of the antiepileptic drug, the technique may, when combined w/continuous blood level monitoring, also offer information concerning the time of onset and the duration of the AED action. In some cases, the maximal reduction of the photosensitive range is not concurrent w/but delayed in relation to the time of the peak blood levels of a drug. Using the classical photoparoxysmal response as a model, the effect of the experimental AED on the distribution of the epileptiform activity may help predict the clinical anti-convulsive spectrum of the new drug. It may lead to complete abolishment of the photoparoxysmal response, or alternatively it may also result in the inhibition of the secondary spread and generalization of the primary epileptiform discharges in the occipital lobe.
SPECIFIC AIMS : This study intends to obtain clinical data that evaluates the acute antiepileptic effects of RWJ-333369 in photosensitive epilepsy patients using the photoparoxysmal EEG response to intermittent photic stimulation (IPS) as a marker of antiepileptic activity. This study also proposes to determine an oral dose of RWJ-333369 that results in complete of photosensitivity or reduces the photosensitivity range by at least three points on the photosensitivity scale in at least one eye condition (open, closure or closed). In addition, an assessment of the relationship of the antiepileptic effect of RWJ-333369 to the plasma levels of RWJ-333369 will be examined as well as an investigation into the possible interactions w/pre-existing antiepileptic drugs (AEDs). Another objective of this study is to obtain information on the safety and tolerability of RWJ-333369 in patients w/photosensitive epilepsy and to investigate the acute effect of RWJ-333369 on the mood of patients w/photosensitive epilepsy.
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