PURPOSE: This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy. METHOD: This study was carried out between September 2010 and December 2011 at 16 Italian and 1 German neurologic centers. Lacosamide was added to the baseline therapy at a starting dose of 1 mg/kg/day in patients aged <16 years (group A) and 100 mg daily in subjects aged 16 and older (group B), and titrated to the target dose, ranging from 3 to 12 mg/kg/day or from 100 to 600 mg daily, respectively. After completing the titration period, patients entered a 12-month maintenance period and they were followed up at 3, 6 and 12 months. The primary assessment of efficacy was based on the change from baseline in seizure frequency per 28 days and was evaluated at 3, 6 and 12 months as follows: number and proportion of 100% responders, 50% responders, non-responders and worsening patients. Safety evaluation was also performed at 3, 6 and 12 months. RESULTS: A total of 118 patients (59 group A, 59 group B) with uncontrolled generalized and focal epilepsy were enrolled. Patient mean±SD age was 15.9±6.80 years and the age range was 4-38 years. At 3-month evaluation, of 118 treated patients 56 subjects (47.4% group A; 47.4% group B; p=0.8537) experienced at least a 50% reduction in seizure frequency. At 6 and 12-month follow-up, the 50% responders were 57 (52.5% group A; 44.1% group B; p=0.4612) and 51 (47.4% group A; 39% group B; p=0.4573), respectively. Thirty-five subjects (30.5% group A; 28.8% group B; p=1) experienced side effects during the treatment period. The most common adverse events were dyspepsia for group A and dizziness for group B. CONCLUSION: Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures.
PURPOSE: This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy. METHOD: This study was carried out between September 2010 and December 2011 at 16 Italian and 1 German neurologic centers. Lacosamide was added to the baseline therapy at a starting dose of 1 mg/kg/day in patients aged <16 years (group A) and 100 mg daily in subjects aged 16 and older (group B), and titrated to the target dose, ranging from 3 to 12 mg/kg/day or from 100 to 600 mg daily, respectively. After completing the titration period, patients entered a 12-month maintenance period and they were followed up at 3, 6 and 12 months. The primary assessment of efficacy was based on the change from baseline in seizure frequency per 28 days and was evaluated at 3, 6 and 12 months as follows: number and proportion of 100% responders, 50% responders, non-responders and worsening patients. Safety evaluation was also performed at 3, 6 and 12 months. RESULTS: A total of 118 patients (59 group A, 59 group B) with uncontrolled generalized and focal epilepsy were enrolled. Patient mean±SD age was 15.9±6.80 years and the age range was 4-38 years. At 3-month evaluation, of 118 treated patients 56 subjects (47.4% group A; 47.4% group B; p=0.8537) experienced at least a 50% reduction in seizure frequency. At 6 and 12-month follow-up, the 50% responders were 57 (52.5% group A; 44.1% group B; p=0.4612) and 51 (47.4% group A; 39% group B; p=0.4573), respectively. Thirty-five subjects (30.5% group A; 28.8% group B; p=1) experienced side effects during the treatment period. The most common adverse events were dyspepsia for group A and dizziness for group B. CONCLUSION:Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures.
Authors: Sebastian Bauer; Laurent M Willems; Esther Paule; Christine Petschow; Johann Philipp Zöllner; Felix Rosenow; Adam Strzelczyk Journal: Ther Adv Neurol Disord Date: 2016-11-29 Impact factor: 6.570
Authors: Viktor Farkas; Barbara Steinborn; J Robert Flamini; Ying Zhang; Nancy Yuen; Simon Borghs; Ali Bozorg; Tony Daniels; Paul Martin; Hannah C Carney; Svetlana Dimova; Ingrid E Scheffer Journal: Neurology Date: 2019-08-28 Impact factor: 9.910
Authors: Sinéad B Heavin; Mark McCormack; Stefan Wolking; Lisa Slattery; Nicole Walley; Andreja Avbersek; Jan Novy; Saurabh R Sinha; Rod Radtke; Colin Doherty; Pauls Auce; John Craig; Michael R Johnson; Bobby P C Koeleman; Roland Krause; Wolfram S Kunz; Anthony G Marson; Terence J O'Brien; Josemir W Sander; Graeme J Sills; Hreinn Stefansson; Pasquale Striano; Federico Zara; Chantal Depondt; Sanjay Sisodiya; David Goldstein; Holger Lerche; Gianpiero L Cavalleri; Norman Delanty Journal: Epilepsia Open Date: 2019-09-25
Authors: V Villanueva; B G Giráldez; M Toledo; G J De Haan; E Cumbo; A Gambardella; M De Backer; L Joeres; M Brunnert; P Dedeken; J Serratosa Journal: Acta Neurol Scand Date: 2018-03-14 Impact factor: 3.209