Abstract | BACKGROUND: METHODS: This study was an 18-week, multicenter, randomized double-blind trial of gradual conversion to ESL monotherapy in adults with POS not well controlled by 1-2 antiepileptic drugs (AEDs), using historical data as the control. The study comprised an 8-week baseline period, a 2-week titration period, a 6-week AED conversion period, a 10-week monotherapy period, and either a 1-week taper period or optional entry to an open-label extension study. The primary endpoint compared the Kaplan-Meier (KM)-estimated 112-day exit rate with a threshold value calculated from the historical controls. RESULTS: There were 172 randomized patients; 154 (90%) entered the AED conversion period and 121 (70%) completed the study. The KM-estimated exit rates [confidence interval (CI)] were 15.6% [8.1-28.7%] for ESL 1200 mg, and 12.8% [7.5-21.5%] for ESL 1600 mg. The upper limits of the 95% CI KM-estimates were below the pre-specified threshold for historical control of 65.3%, indicating that ESL was efficacious in reducing seizure-related exits, compared with historical control. During the 18-week double-blind treatment period, median reductions in standardized seizure frequency occurred with ESL 1200 mg (36.1%) and ESL 1600 mg (47.5%). The responder rates (a 50% or greater reduction in seizure frequency from baseline) during the 18-week double-blind period and the monotherapy period, respectively, were 35.2% and 38.9% for ESL 1200 mg, and 46.0% and 46.0% for ESL 1600 mg. The overall adverse event profile was consistent with the known safety profile of ESL. CONCLUSIONS: These findings indicate that ESL monotherapy (1200 and 1600 mg QD) was efficacious and well tolerated in this study. TRIAL REGISTRATION: NCT01091662 ; EudraCT No. 2010-018684-42.
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Authors | Mercedes P Jacobson, Ladislav Pazdera, Perminder Bhatia, Todd Grinnell, Hailong Cheng, David Blum, study 046 team |
Journal | BMC neurology
(BMC Neurol)
Vol. 15
Pg. 46
(Mar 28 2015)
ISSN: 1471-2377 [Electronic] England |
PMID | 25880756
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Dibenzazepines
- eslicarbazepine acetate
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Topics |
- Adolescent
- Adult
- Aged
- Anticonvulsants
(therapeutic use)
- Dibenzazepines
(therapeutic use)
- Double-Blind Method
- Epilepsies, Partial
(drug therapy)
- Female
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Seizures
(drug therapy)
- Treatment Outcome
- Young Adult
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