dc.contributor.author |
Farkas, Viktor |
|
dc.contributor.author |
Steinborn, Barbara |
|
dc.contributor.author |
Flamini, J Robert |
|
dc.contributor.author |
Zhang, Ying |
|
dc.contributor.author |
Yuen, Nancy |
|
dc.contributor.author |
Borghs, Simon |
|
dc.contributor.author |
Bozorg, Ali |
|
dc.contributor.author |
Daniels, Tony |
|
dc.contributor.author |
Martin, Paul |
|
dc.contributor.author |
Carney, Hannah C |
|
dc.contributor.author |
Dimova, Svetlana |
|
dc.contributor.author |
Scheffer, Ingrid E |
|
dc.contributor.author |
SP0969 Study Group |
|
dc.date.accessioned |
2021-06-21T06:35:54Z |
|
dc.date.available |
2021-06-21T06:35:54Z |
|
dc.date.issued |
2019 |
|
dc.identifier.citation |
journalVolume=93;journalIssueNumber=12;journalTitle=NEUROLOGY;pagerange=e1212-e1226;journalAbbreviatedTitle=NEUROLOGY; |
|
dc.identifier.uri |
http://repo.lib.semmelweis.hu//handle/123456789/7940 |
|
dc.identifier.uri |
doi:10.1212/WNL.0000000000008126 |
|
dc.description.abstract |
To evaluate efficacy and tolerability of adjunctive lacosamide in children and adolescents with uncontrolled focal (partial-onset) seizures.In this double-blind trial (SP0969; NCT01921205), patients (age ≥4-<17 years) with uncontrolled focal seizures were randomized (1:1) to adjunctive lacosamide/placebo. After a 6-week titration, patients who reached the target dose range for their weight (<30 kg: 8-12 mg/kg/d oral solution; ≥30-<50 kg: 6-8 mg/kg/d oral solution; ≥50 kg: 300-400 mg/d tablets) entered a 10-week maintenance period. The primary outcome was change in focal seizure frequency per 28 days from baseline to maintenance.Three 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%).Adjunctive lacosamide was efficacious in reducing seizure frequency and generally well tolerated in patients (age ≥4-<17 years) with focal seizures.NCT01921205.This trial provides Class I evidence that for children and adolescents with uncontrolled focal seizures, adjunctive lacosamide reduces seizure frequency. |
|
dc.format.extent |
e1212-e1226 |
|
dc.relation.ispartof |
urn:issn:0028-3878 |
|
dc.title |
Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures |
|
dc.type |
Journal Article |
|
dc.date.updated |
2019-10-30T12:16:26Z |
|
dc.language.rfc3066 |
en |
|
dc.rights.holder |
NULL |
|
dc.identifier.mtmt |
30868964 |
|
dc.identifier.pubmed |
31462582 |
|
dc.contributor.department |
SE/AOK/K/I. Sz. Gyermekgyógyászati Klinika |
|
dc.contributor.institution |
Semmelweis Egyetem |
|