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, Renzo Guerrini

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Purpose: Carisbamate, 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. Methods: Eighteen 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 8 h 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. Results: Carisbamate 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. Conclusion: This 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.

Original languageEnglish
Pages (from-to)193-200
Number of pages8
JournalEpilepsy Research
Volume74
Issue number2-3
DOIs
Publication statusPublished - May 2007

Fingerprint

Anticonvulsants
Placebos
Photic Stimulation
S-2-O-carbamoyl-1-o-chlorophenyl-ethanol
Valproic Acid
Dizziness
Pharmaceutical Preparations
Nausea
Epilepsy

Keywords

  • Antiepileptic drug
  • Carisbamate
  • Intermittent photic stimulation
  • Photoparoxysmal responses
  • Photosensitivity

ASJC Scopus subject areas

  • Clinical Neurology
  • Pediatrics, Perinatology, and Child Health
  • Neurology

Cite this

Evaluation of carisbamate, a novel antiepileptic drug, in photosensitive patients : An exploratory, placebo-controlled study. / Trenité, Dorothée G A Kasteleijn Nolst; French, Jacqueline A.; Hirsch, Edouard; Macher, Jean Paul; Meyer, Bernd Ulrich; Grosse, Pascal A.; Abou-Khalil, Bassel W.; Rosenfeld, William E.; van Gerven, Joop; Novak, Gerald P.; Parmeggiani, Lucio; Schmidt, Bernd; Gibson, David; Guerrini, Renzo.

In: Epilepsy Research, Vol. 74, No. 2-3, 05.2007, p. 193-200.

Research output: Contribution to journalArticle

Trenité, DGAKN, French, JA, Hirsch, E, Macher, JP, Meyer, BU, Grosse, PA, Abou-Khalil, BW, Rosenfeld, WE, van Gerven, J, Novak, GP, Parmeggiani, L, Schmidt, B, Gibson, D & Guerrini, R 2007, 'Evaluation of carisbamate, a novel antiepileptic drug, in photosensitive patients: An exploratory, placebo-controlled study', Epilepsy Research, vol. 74, no. 2-3, pp. 193-200. https://doi.org/10.1016/j.eplepsyres.2007.03.012
Trenité, Dorothée G A Kasteleijn Nolst ; French, Jacqueline A. ; Hirsch, Edouard ; Macher, Jean Paul ; Meyer, Bernd Ulrich ; Grosse, Pascal A. ; Abou-Khalil, Bassel W. ; Rosenfeld, William E. ; van Gerven, Joop ; Novak, Gerald P. ; Parmeggiani, Lucio ; Schmidt, Bernd ; Gibson, David ; Guerrini, Renzo. / Evaluation of carisbamate, a novel antiepileptic drug, in photosensitive patients : An exploratory, placebo-controlled study. In: Epilepsy Research. 2007 ; Vol. 74, No. 2-3. pp. 193-200.
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