Journal article
A randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of adjunctive carisbamate treatment in patients with partial-onset seizures
JJ Halford, E Ben-Menachem, P Kwan, S Ness, J Schmitt, M Eerdekens, G Novak
Epilepsia | WILEY | Published : 2011
Abstract
Purpose: To assess the efficacy, safety, and tolerability of adjunctive carisbamate treatment at 800 mg/day and 1,200 mg/day in patients with partial-onset seizures (POS). Methods: Patients â?¥16 years of age with an established diagnosis of POS for â?¥1 year and uncontrolled on one to three antiepileptic drugs were enrolled. Eligible patients remained on stable doses of prescribed antiepileptic drugs for an 8-week pretreatment baseline phase and were then randomized (1:1:1) to receive carisbamate (800 mg/day or 1,200 mg/day), or placebo, for a 14-week double-blind phase. Primary efficacy endpoints were percentage reduction in POS frequency and responder rate (patients with â?¥50% reduction ..
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Funding Acknowledgements
[ "Funded by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A. The sponsor also provided a formal review of this manuscript.", "Dr. Halford has received honoraria from Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and from Lundbeck, Inc. for consulting. Dr. Kwan has provided advisory board service for Johnson & Johnson Pharmaceutical Research & Development, L.L.C, and Pfizer. He has served on speaker's bureau for Eisai, and receives research grants from Eisai, Johnson & Johnson, Pfizer, and UCB Pharma. Dr. Ben-Menachem served during the past year on a scientific board for Eisai and UCB and Lundbeck Inc. (formerly Ovation Pharmaceuticals, Inc.). She serves on a speaker's bureau for Eisai, Janssen-Cilag, UCB, and receives research support from Johnson & Johnson, UCB, and Eisai Inc. Drs. Ness and Novak and Ms. Schmitt are employees of Johnson & Johnson Pharmaceutical Research & Development, LLC. Dr. Eerdekens was employed by Johnson & Johnson Pharmaceutical Research & Development at the time of the study. All authors met ICMJE criteria and all those who fulfilled those criteria are listed as authors. All authors had access to the study data and made the final decision about where to publish these data and approved submission to the journal. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines." ]