Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study.
OBJECTIVE
This open-label extension evaluated the long-term efficacy and tolerability of rufinamide in patients with Lennox-Gastaut syndrome (LGS) who had previously completed a 12-week double-blind study.


METHODS
In total, 124 patients (aged 4-37 years), receiving 1-3 concomitant antiepileptic drugs, were treated with rufinamide approximately 25-60 mg/kg/day. Efficacy was assessed by seizure frequency; tolerability by adverse events (AEs) and laboratory tests.


RESULTS
Overall, patients were treated with rufinamide for a median (range) of 432 (10-1149) days. Reductions in seizure frequency were observed throughout the study; during the last 12 months of treatment, 41.0% and 47.9% of patients had > or = 50% reduction in total and tonic-atonic seizure frequency, respectively. The most common AEs were vomiting (30.6%) and pyrexia (25.8%).


CONCLUSIONS
In this open-label extension, rufinamide appeared to be an effective long-term adjunctive therapy for the treatment of LGS-associated seizures in children and young adults.
Kluger
G
G
BHZ Vogtareuth, Vogtareuth, Germany.
Glauser
T
T
Krauss
G
G
Seeruthun
R
R
Perdomo
C
C
Arroyo
S
S
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination / Q000379:methods; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D055815:Young Adult
D000927:Anticonvulsants; D014230:Triazoles; C079703:rufinamide