• Epilepsy research · May 2007

    Multicenter Study Clinical Trial

    Evaluation of carisbamate, a novel antiepileptic drug, in photosensitive patients: an exploratory, placebo-controlled study.

    • Dorothée G A Kasteleijn-Nolst Trenité, Jacqueline A French, Edouard Hirsch, Jean-Paul Macher, Bernd-Ulrich Meyer, Pascal A Grosse, Bassel W Abou-Khalil, William E Rosenfeld, Joop van Gerven, Gerald P Novak, Lucio Parmeggiani, Bernd Schmidt, David Gibson, and Renzo Guerrini.
    • University La Sapienza II, Via Vitorchiano 81, 00189 Roma, Italy. dkasteleijn@planet.nl <dkasteleijn@planet.nl>
    • Epilepsy Res. 2007 May 1;74(2-3):193-200.

    PurposeCarisbamate, a novel neuromodulatory agent with antiepileptic properties, was evaluated in patients with photoparoxysmal responses to intermittent photic stimulation (IPS) in this multicenter, non-randomized, single-blind, placebo-controlled, proof-of-concept study.MethodsEighteen Caucasian patients (14 females, 4 males) with a mean age of 30 years (range: 16-51 years) underwent standardized IPS under three eye conditions (during eye closure, eyes closed and eyes open) at hourly intervals for up to 8h after receiving placebo (Day 1), carisbamate (Day 2) and placebo (Day 3). Carisbamate was given at single doses of 250-1000 mg. All patients received one or two concomitant antiepileptic drugs, most commonly valproate.ResultsCarisbamate produced a dose-dependent reduction in photosensitivity in the 13 evaluable patients, with abolishment of photoparoxysmal responses in 3 patients and clinically significant suppression of such responses in 7 additional patients. Photosensitivity was abolished or reduced in all five patients in the 1000-mg dose group. The onset of carisbamate occurred rapidly, with clinically significant suppression achieved before or near the time peak plasma drug levels were reached. The duration of action was dose-related and long-lasting, with clinically significant reductions of photosensitivity observed for up to 32 h after doses of 750 or 1000 mg. Carisbamate was generally well tolerated, with dizziness and nausea reported more frequently after active drug than placebo.ConclusionThis study shows that carisbamate exhibits dose-related antiepileptic effects in the photosensitivity model. Randomized, controlled studies of carisbamate in epilepsy patients inadequately controlled by their existing AED therapy are warranted.

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