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From the University of Alabama School of Medicine and Department of Veterans' Affairs Medical Center Birmingham (E.F.), AL; Dartmouth Medical School (G.L.H.), Lebanon, NH; The Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; and Johnson & Johnson Pharmaceutical Research & Development (G.N., W.N., A.G., J.S., E.Y., S.R., M.H.), L.L.C., Raritan, NJ.
Address correspondence and reprint requests to Dr. Edward Faught, University of Alabama at Birmingham Epilepsy Center, Civitan International Research Center 312, 1719 6th Ave. South, Birmingham, AL 35294-0021 faught{at}uab.edu
Objective: To evaluate the efficacy, safety, and tolerability of carisbamate (CRS), an investigational drug, as adjunctive treatment for partial-onset seizures in adults.
Methods: A randomized, double-blind, placebo-controlled, multicenter, dose-ranging study was conducted in 12 countries. Patients counted seizures during an 8-week baseline period, and then, if eligible, entered a double-blind phase consisting of a 4-week dose-titration period (target CRS doses: 100, 300, 800, or 1,600 mg/d or placebo in two divided doses) and a 12-week maintenance period. The primary efficacy variable was percent reduction in partial-onset seizure frequency during the double-blind phase compared with pretreatment baseline. Safety data and responder rates were also assessed.
Results: Five hundred thirty-seven patients were randomized, and 82% completed the study. In the intent-to-treat population (n = 533), CRS at doses of 
300 mg/d (p 
0.006) reduced the frequency of partial-onset seizures vs placebo: 6% (placebo) vs 24% (300 mg/d), 21% (800 mg/d), and 29% (1,600 mg/d) for CRS. Adverse events consisted primarily of CNS effects, and led to discontinuation of drug in 8% of the placebo group vs 5% (100 mg/d), 6% (300 mg/d), 12% (800 mg/d), and 19% (1,600 mg/d) of the CRS groups.
Conclusions: Carisbamate at doses of 300, 800, and 1,600 mg/d was effective as adjunctive therapy for reducing the frequency of partial-onset seizures.
GLOSSARY: AED = antiepileptic drug; ALT = alanine aminotransferase; AST = aspartate aminotransferase; CRS = carisbamate; LFT = liver function test; TEAE = treatment-emergent adverse event; UGT = uridine diphosphate glucuronosyltransferase.
Received March 21, 2008. Accepted in final form August 7, 2008.
Supported by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.
This study is registered at ClinicalTrials.gov (NCT00210522) corresponding to protocol identifier CR002191.
Disclosures: E.F. was a principal investigator for this study and a consultant in its design and has received honoraria from Johnson & Johnson for speaking and consulting. G.L.H. was a principal investigator for this study and has received research support and honoraria for consulting from Johnson & Johnson. W.E.R. was a principal investigator for this study and a consultant in its design and has received honoraria from Johnson & Johnson for speaking and consulting. G.N., W.N., A.G., J.S., and M.H. are employed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Some of these data were previously presented at the American Epilepsy Society, December 2007, Philadelphia, PA.
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