To evaluate the efficacy and safety of 2 regimens of tiagabine as add-on therapy for patients with complex partial seizures (CPSs) that are refractory to other treatment.
Randomized, double-blind, placebocontrolled, add-on, parallel-group trial with an 8-week baseline period, 12-week experimental period (4 weeks of dose titration and 8 weeks of fixed-dose therapy), and 4-week termination period.
Twenty-six centers throughout the United States.
Three hundred fifty-one patients were enrolled, 318 were entered in the double-blind period, and 271 completed the study.
Tiagabine, 16 mg 2 times per day (106 patients); tiagabine, 8 mg 4 times daily (105 patients); and placebo (107 patients). The doses of tiagabine were titrated in 3 steps to the fixed dose.
Main Outcome Measure:
The median change in the 4-week rate of CPSs from baseline to experimental period.
The median change from baseline was −1.6 CPSs per 4 weeks in the group of patients who were given tiagabine 2 times per day, and it was −1.2 CPSs in the group of patients who were given tiagabine 4 times per day (P=.06 and P=.02, respectively, compared with placebo). The 4-week seizure frequency was reduced by 50% or more in 31% of the patients who were given tiagabine 2 times per day and in 27% of the patients who were given tiagabine 4 times per day vs 10% of the placebo-treated patients (P≤.001 for each tiagabine-treated group compared with the placebo group). The most frequent adverse events involved the central nervous system and occurred in comparable proportions in the 3 treatment groups. Similar proportions of patients discontinued the study prematurely for adverse events.
Tiagabine administered 2 and 4 times daily as add-on pharmacotherapy was effective in reducing CPSs in patients with epilepsy whose conditions were refractory to treatment with other antiepileptic agents, and it was well tolerated.
Sachdeo RC, Leroy RF, Krauss GL, Drake ME, Green PM, Leppik IE, Shu VS, Ringham GL, Sommerville KW. Tiagabine Therapy for Complex Partial SeizuresA Dose-Frequency Study. Arch Neurol. 1997;54(5):595-601. doi:10.1001/archneur.1997.00550170069016