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May 1997

Tiagabine Therapy for Complex Partial Seizures: A Dose-Frequency Study

Author Affiliations

From the Department of Neurology, University of Medicine and Dentistry of New Jersey, New Brunswick (Dr Sachdeo); the Neurological Clinic of Texas, Dallas (Dr Leroy); Department of Neurology, The Johns Hopkins Hospital, Baltimore, Md (Dr Krauss); Department of Neurology, the Ohio State University Medical Center, Columbus (Dr Drake); the Kalamazoo Neurology PC, Kalamazoo, Mich (Dr Green); the MINCEP Epilepsy Care, Minneapolis, Minn (Dr Leppik); and Neurotherapeutics Venture and Department of Statistics, Abbott Laboratories, North Chicago, Ill (Drs Shu, Ringham, and Sommerville).

Arch Neurol. 1997;54(5):595-601. doi:10.1001/archneur.1997.00550170069016

Objective:  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.

Design:  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.

Setting:  Twenty-six centers throughout the United States.

Patients:  Three hundred fifty-one patients were enrolled, 318 were entered in the double-blind period, and 271 completed the study.

Interventions:  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.

Results:  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.

Conclusions:  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.