PMID- 20887365
OWN - NLM
STAT- MEDLINE
DCOM- 20110401
LR  - 20171116
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 52
IP  - 2
DP  - 2011 Feb
TI  - A randomized, double-blind, placebo-controlled, parallel-group study of 
      rufinamide as adjunctive therapy for refractory partial-onset seizures.
PG  - 234-42
LID - 10.1111/j.1528-1167.2010.02729.x [doi]
AB  - PURPOSE: Efficacy and safety of adjunctive rufinamide (3,200 mg/day) was assessed 
      in adolescents and adults with inadequately controlled partial-onset seizures 
      receiving maintenance therapy with up to three antiepileptic drugs (AEDs). 
      METHODS: This randomized, double-blind, placebo-controlled, parallel-group, 
      multicenter study comprised a 56-day baseline phase (BP), 12-day titration phase, 
      and 84-day maintenance phase (MP). The primary efficacy variable was percentage 
      change in total partial seizure frequency per 28 days (MP vs. BP). Secondary 
      efficacy outcome measures included >/=50% responder rate and reduction in mean 
      total partial seizure frequency during the MP. Safety and tolerability evaluation 
      included adverse events (AEs), physical and neurologic examinations, and 
      laboratory values. Pharmacokinetic and pharmacodynamic assessments were 
      conducted. RESULTS: Three hundred fifty-seven patients were randomized: 176 to 
      rufinamide and 181 to placebo. Patients had a median of 13.3 seizures per 28 days 
      during BP; 86% were receiving >/=2 AEDs. For the intent-to-treat population, the 
      median percentage reduction in total partial seizure frequency per 28 days was 
      23.25 for rufinamide versus 9.80 for placebo (p = 0.007). Rufinamide-treated 
      patients were more than twice as likely to have had a >/=50% reduction in partial 
      seizure frequency (32.5% vs. 14.3%; p < 0.001) and had a greater reduction in 
      median total partial seizure rate per 28 days during the MP (13.2 vs. 5.2; p < 
      0.001). Treatment-emergent AEs occurring at >/=5% higher incidence in the 
      rufinamide group compared with placebo were dizziness, fatigue, nausea, 
      somnolence, and diplopia. CONCLUSIONS: Adjunctive treatment with rufinamide 
      reduced total partial seizures in refractory patients. AEs reported were 
      consistent with the known tolerability profile of rufinamide.
CI  - Wiley Periodicals, Inc. (c) 2010 International League Against Epilepsy.
FAU - Biton, Victor
AU  - Biton V
AD  - Arkansas Epilepsy Program, Little Rock, Arkansas 72205, USA. 
      vbiton@clinicaltrialsinc.com
FAU - Krauss, Gregory
AU  - Krauss G
FAU - Vasquez-Santana, Blanca
AU  - Vasquez-Santana B
FAU - Bibbiani, Francesco
AU  - Bibbiani F
FAU - Mann, Allison
AU  - Mann A
FAU - Perdomo, Carlos
AU  - Perdomo C
FAU - Narurkar, Milind
AU  - Narurkar M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100930
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Triazoles)
RN  - WFW942PR79 (rufinamide)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/adverse effects/pharmacokinetics/*therapeutic use
MH  - Child
MH  - Data Interpretation, Statistical
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Resistance
MH  - Epilepsies, Partial/*drug therapy
MH  - Humans
MH  - Middle Aged
MH  - Sample Size
MH  - Seizures/*drug therapy
MH  - Triazoles/adverse effects/pharmacokinetics/*therapeutic use
MH  - Young Adult
EDAT- 2010/10/05 06:00
MHDA- 2011/04/02 06:00
CRDT- 2010/10/05 06:00
PHST- 2010/10/05 06:00 [entrez]
PHST- 2010/10/05 06:00 [pubmed]
PHST- 2011/04/02 06:00 [medline]
AID - 10.1111/j.1528-1167.2010.02729.x [doi]
PST - ppublish
SO  - Epilepsia. 2011 Feb;52(2):234-42. doi: 10.1111/j.1528-1167.2010.02729.x. Epub 
      2010 Sep 30.