Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures
| Autor: | Tony Daniels, Paul Martin, Ying Zhang, Nancy Yuen, Simon Borghs, Svetlana Dimova, Barbara Steinborn, Hannah C. Carney, Ali Bozorg, Viktor Farkas, Ingrid E. Scheffer, J. Robert Flamini |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Lacosamide Adolescent Placebo-controlled study Placebo Article law.invention 03 medical and health sciences Epilepsy 0302 clinical medicine Randomized controlled trial Double-Blind Method law Seizures medicine Humans 030212 general & internal medicine Prospective Studies Adverse effect Child business.industry medicine.disease Discontinuation Treatment Outcome Tolerability Anesthesia Child Preschool Anticonvulsants Drug Therapy Combination Female Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Neurology |
| ISSN: | 1526-632X 0028-3878 |
| Popis: | ObjectiveTo evaluate efficacy and tolerability of adjunctive lacosamide in children and adolescents with uncontrolled focal (partial-onset) seizures.MethodsIn this double-blind trial (SP0969;NCT01921205), patients (age ≥4–ResultsThree hundred forty-three patients were randomized; 306 (lacosamide 152 of 171 [88.9%]; placebo 154 of 172 [89.5%]) completed treatment (titration and maintenance). Adverse events (AEs) were the most common reasons for discontinuation during treatment (lacosamide 4.1%; placebo 5.8%). From baseline to maintenance, percent reduction in focal seizure frequency per 28 days for lacosamide (n = 170) vs placebo (n = 168) was 31.7% (p= 0.0003). During maintenance, median percent reduction in focal seizure frequency per 28 days was 51.7% for lacosamide and 21.7% for placebo. Fifty percent responder rates (≥50% reduction) were 52.9% and 33.3% (odds ratio 2.17,p= 0.0006). During treatment, treatment-emergent AEs were reported by 67.8% lacosamide-treated patients (placebo 58.1%), most commonly (≥10%) somnolence (14.0%, placebo 5.2%) and dizziness (10.5%, placebo 3.5%).ConclusionsAdjunctive lacosamide was efficacious in reducing seizure frequency and generally well tolerated in patients (age ≥4–ClinicalTrials.gov identifier:NCT01921205.Classification of evidenceThis trial provides Class I evidence that for children and adolescents with uncontrolled focal seizures, adjunctive lacosamide reduces seizure frequency. |
| Databáze: | OpenAIRE |
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