Losigamone add-on therapy in partial epilepsy: a placebo-controlled study.
OBJECTIVE
To evaluate the efficacy and tolerability of losigamone (LSG).


METHODS
Double-blind, placebo-controlled add-on study with 3x500 mg LSG/die for the treatment of chronic partial seizures in 203 patients (99 treated with LSG, 104 on placebo).


RESULTS
The median percent change of seizures was 14.9% (LSG) versus 6.7% (placebo) (P=0.004). Seizure frequency was decreased by more than 50% in 22.3% (LSG) and 14.6% (placebo) of patients (P=0.13). Mean percent change of seizures was best in patients with only one additional anticonvulsant drug (LSG versus placebo, P=0.004). Adverse events (usually CNS-related side effects of mild to moderate intensity) were reported in 59.6% (LSG) and 37.5% (placebo) of patients.


CONCLUSIONS
LSG proved to be an effective and well tolerated anticonvulsant drug for the treatment of chronic partial seizures.
Bauer
J
J
Department of Epileptology, University of Bonn, Germany, Dr Willmar Schwabe GmbH, Karlsruhe, Germany.
Dienel
A
A
Elger
C E
CE
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D005663:Furans / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000927:Anticonvulsants; D005663:Furans; C065427:losigame