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Eslicarbazepine Acetate: A Double‐blind, Add‐on, Placebo‐controlled Exploratory Trial in Adult Patients with Partial‐onset Seizures
Author(s) -
Elger Christian,
Bialer Meir,
Cramer Joyce A.,
Maia Joana,
Almeida Luis,
SoaresdaSilva Patrício
Publication year - 2007
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1167.2007.00984.x
Subject(s) - medicine , placebo , adverse effect , anesthesia , randomized controlled trial , incidence (geometry) , refractory (planetary science) , clinical endpoint , physics , alternative medicine , pathology , astrobiology , optics
Summary: Objective: To explore the efficacy and safety of eslicarbazepine acetate (BIA 2‐093), a new antiepileptic drug, as adjunctive therapy in adult patients with partial epilepsy. Methods: A multicenter, double‐blind, randomized, placebo‐controlled study was conducted in 143 refractory patients aged 18–65 years with ≥4 partial‐onset seizures/month. The study consisted of a 12‐week treatment period followed by a 1‐week tapering off. Patients were randomly assigned to one of three groups: treatment with eslicarbazepine acetate once daily (QD, n = 50), twice daily (BID, n = 46), or placebo (PL, n = 47). The daily dose was titrated from 400 mg to 800 mg and to 1,200 mg at 4‐week intervals. The proportion of responders (patients with a ≥50% seizure reduction) was the primary end point. Results: The percentage of responders versus baseline showed a statistically significant difference between QD and PL groups (54% vs. 28%; 90% CI =–∞, –14; p = 0.008). The difference between the BID (41%) and PL did not reach statistical significance (90% CI =–∞, –1; p = 0.12). A significantly higher proportion of responders in weeks 5–8 was found in the QD group than in the BID group (58% vs. 33%, respectively, p = 0.022). At the end of the 12‐week treatment, the number of seizure‐free patients in the QD and BID groups was 24%, which was significantly different from the PL group. The incidence of adverse events was similar between the treatment groups and no drug‐related serious adverse events occurred. Conclusion: Eslicarbazepine acetate was efficacious and well tolerated as an adjunctive therapy of refractory epileptic patients.