TY - JOUR
T1 - Evaluation of carisbamate, a novel antiepileptic drug, in photosensitive patients
T2 - An exploratory, placebo-controlled study
AU - Trenité, Dorothée G.A.Kasteleijn Nolst
AU - French, Jacqueline A.
AU - Hirsch, Edouard
AU - Macher, Jean Paul
AU - Meyer, Bernd Ulrich
AU - Grosse, Pascal A.
AU - Abou-Khalil, Bassel W.
AU - Rosenfeld, William E.
AU - van Gerven, Joop
AU - Novak, Gerald P.
AU - Parmeggiani, Lucio
AU - Schmidt, Bernd
AU - Gibson, David
AU - Guerrini, Renzo
N1 - Funding Information:
We would like to thank the EEG technicians and nurses from the respective study centers; Peter Edelbroek from SEIN for analyzing the plasma samples of the AEDs; and Laurie Theurer for her administrative help. Johnson and Johnson supplied the study drug and sponsored the study. D.G.A. Kasteleijn-Nolst Trenité is supported by the EU FP6 grant—Marie Curie Excellence Chair number 024224: Visual Sensitivity.
PY - 2007/5
Y1 - 2007/5
N2 - 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.
AB - 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.
KW - Antiepileptic drug
KW - Carisbamate
KW - Intermittent photic stimulation
KW - Photoparoxysmal responses
KW - Photosensitivity
UR - http://www.scopus.com/inward/record.url?scp=34247598478&partnerID=8YFLogxK
U2 - 10.1016/j.eplepsyres.2007.03.012
DO - 10.1016/j.eplepsyres.2007.03.012
M3 - Article
C2 - 17448639
AN - SCOPUS:34247598478
SN - 0920-1211
VL - 74
SP - 193
EP - 200
JO - Epilepsy Research
JF - Epilepsy Research
IS - 2-3
ER -