Rufinamide for refractory focal seizures: an open-label, multicenter European study.
OBJECTIVE
The present study aimed to assess the efficacy and tolerability of rufinamide as adjunctive drug for the treatment of a large series of children, adolescents and adults with refractory cryptogenic or symptomatic focal epilepsy.


METHODS
Patients were recruited in a prospective, add-on, open-label treatment study from six Italian and one German centers for pediatric and adolescent epilepsy care. Inclusion criteria were: (1) age 3 years or more; (2) diagnosis of cryptogenic or symptomatic focal epilepsy refractory to at least three previous antiepileptic drugs (AEDs), alone or in combination; (3) more than one seizure per month in the last 6 months; (4) use of at least one other AED, but no more than three, at baseline; (5) informed consent from parents and/or caregivers.


RESULTS
Sixty-eight patients (40 males, 28 females), aged between 3 and 63 years (mean 19.9 years, median 16.0)±SD 12.58, with cryptogenic (28 pts, 41.2%) or symptomatic focal epilepsy (40 pts, 58.8%), were recruited in the study. After a mean follow-up period of 10.4±10.29 months, twenty-two patients (32.3%) had a 50-99% seizure reduction, and none became seizure-free. Twelve patients (17.6%) had a 25-49% seizure decrease, while in 30 (44.1%) seizure frequency was unchanged. A seizure worsening was reported in 5 patients (7.3%). A better response to rufinamide occurred in frontal lobe seizures (51.6%) and secondary generalized tonic-clonic seizures (50%).


CONCLUSIONS
Rufinamide was effective against focal-onset seizures, particularly in the treatment of secondary generalized frontal lobe seizures.
Child and Adolescent Neuropsychiatry, Medical School, University of Salerno, Italy. gcoppola@unisa.it
Giangennaro
G
Coppola
Nelia
N
Zamponi
Gerhard
G
Kluger
Arndt
A
Mueller
Mazzotta
M
Anna Rita
Pasquale
P
Parisi
Claudia
C
Isone
Elena
E
Santoro
Paolo
P
Curatolo
Alberto
A
Verrotti
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000097:blood / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012640:Seizures / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome; D014230:Triazoles / Q000097:blood / Q000627:therapeutic use*; D055815:Young Adult
D000927:Anticonvulsants; D014230:Triazoles; C079703:rufinamide