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Statements

Subject Item
n2:RIV%2F00216224%3A14740%2F14%3A00074858%21RIV15-MSM-14740___
rdf:type
n13:Vysledek skos:Concept
rdfs:seeAlso
http://onlinelibrary.wiley.com/doi/10.1111/epi.12391/abstract
dcterms:description
PurposeTo evaluate the safety and tolerability of adjunctive brivaracetam (BRV), a high-affinity synaptic vesicle protein 2A (SV2A) ligand, in adults with uncontrolled epilepsy. Efficacy was also assessed in patients with focal seizures as a secondary objective, and explored by descriptive analysis in patients with generalized seizures. MethodsThis was a phase III, randomized, double-blind, placebo (PBO)-controlled flexible dose trial (N01254/NCT00504881) in adults (16-70years) with uncontrolled epilepsy (up to 20% could be patients with generalized epilepsy). After a prospective 4-week baseline, patients were randomized (3:1) to b.i.d. BRV or PBO, initiated at 20mg/day and increased, as needed, to 150mg/day during an 8-week dose-finding period. This was followed by an 8-week stable-dose maintenance period. The treatment period comprised the dose-finding period plus the maintenance period (16weeks). PurposeTo evaluate the safety and tolerability of adjunctive brivaracetam (BRV), a high-affinity synaptic vesicle protein 2A (SV2A) ligand, in adults with uncontrolled epilepsy. Efficacy was also assessed in patients with focal seizures as a secondary objective, and explored by descriptive analysis in patients with generalized seizures. MethodsThis was a phase III, randomized, double-blind, placebo (PBO)-controlled flexible dose trial (N01254/NCT00504881) in adults (16-70years) with uncontrolled epilepsy (up to 20% could be patients with generalized epilepsy). After a prospective 4-week baseline, patients were randomized (3:1) to b.i.d. BRV or PBO, initiated at 20mg/day and increased, as needed, to 150mg/day during an 8-week dose-finding period. This was followed by an 8-week stable-dose maintenance period. The treatment period comprised the dose-finding period plus the maintenance period (16weeks).
dcterms:title
Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: Results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: Results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial
skos:prefLabel
Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: Results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: Results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial
skos:notation
RIV/00216224:14740/14:00074858!RIV15-MSM-14740___
n3:aktivita
n15:P
n3:aktivity
P(ED1.1.00/02.0068)
n3:cisloPeriodika
1
n3:dodaniDat
n10:2015
n3:domaciTvurceVysledku
n17:9233075
n3:druhVysledku
n16:J
n3:duvernostUdaju
n11:S
n3:entitaPredkladatele
n9:predkladatel
n3:idSjednocenehoVysledku
1654
n3:idVysledku
RIV/00216224:14740/14:00074858
n3:jazykVysledku
n20:eng
n3:klicovaSlova
Brivaracetam; Epilepsy; Seizures; Antiepileptic drug; Synaptic vesicle protein 2A
n3:klicoveSlovo
n4:Synaptic%20vesicle%20protein%202A n4:Brivaracetam n4:Epilepsy n4:Antiepileptic%20drug n4:Seizures
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[9A1CBF6B554A]
n3:nazevZdroje
Epilepsia
n3:obor
n19:FH
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
6
n3:projekt
n14:ED1.1.00%2F02.0068
n3:rokUplatneniVysledku
n10:2014
n3:svazekPeriodika
55
n3:tvurceVysledku
Rektor, Ivan Lu, Sarah Paesschen, Wim Van Johnson, Martin E. Kwan, Patrick Trinka, Eugen
n3:wos
000329893900006
s:issn
0013-9580
s:numberOfPages
9
n7:doi
10.1111/epi.12391
n5:organizacniJednotka
14740