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Tiagabine for Complex Partial Seizures
A Randomized, Add-on, Dose-Response Trial
Basim M. Uthman, MD;
A. James Rowan, MD;
Peter A. Ahmann, MD;
Ilo E. Leppik, MD;
Steven C. Schachter, MD;
Kenneth W. Sommerville, MD;
Vincent Shu, PhD
Arch Neurol. 1998;55:56-62.
Objective To determine the efficacy and tolerability of tiagabine, a new antiepileptic drug (AED) that inhibits  -aminobutyric acid (GABA) uptake, at 3 dose levels vs placebo as adjunctive therapy in patients with intractable complex partial seizures (CPS).
Design Randomized, double-blind, placebo-controlled study with a parallel-group, add-on design, starting with a 12-week unblinded baseline phase followed by a 20-week double-blind treatment phase.
Setting Twenty-one US medical centers.
Patients Patients (N=297) aged 12 to 77 years, previously diagnosed as having CPS and receiving stable regimens of 1 to 3 hepatic enzyme-inducing AEDs; divalproex sodium or valproic acid was allowed in combination with any of these drugs.
Interventions Placebo or tiagabine 4 times a day at 16, 32, or 56 mg daily.
Main Outcome Measures Median change in 4-week CPS frequency and adverse events.
Results Median decreases in 4-week CPS frequency for the 32-mg (-2.2) and 56-mg (-2.8) tiagabine groups were significantly greater than for the placebo (-0.7) group (P=.03 and P<.03, respectively); 20% and 29% of patients in the 32- and 56-mg groups had a 50% or greater reduction in the frequency of CPS vs 4% in the placebo group (P=.002 and P<.001, respectively). Adverse effects were similar for placebo and tiagabine except for a significantly greater incidence of dizziness in the 32-mg tiagabine group, tremor in the 32- and 56-mg groups, abnormal thinking (usually mental lethargy or difficulty concentrating) in the 56-mg group, and depressed mood in the 16- and 56-mg groups.
Conclusions Tiagabine is efficacious and well tolerated as adjunctive therapy for CPS; there is a clear dose-response relationship.
From Neurology Services, Veterans Affairs Medical Center, and the Department of Neurology and Brain Institute, University of Florida College of Medicine, Gainesville (Dr Uthman); Bronx Veterans Affairs Medical Center, Bronx, NY (Dr Rowan); Marshfield Clinic, Marshfield, Wis (Dr Ahmann); MINCEP Epilepsy Center and University of Minnesota, Minneapolis (Dr Leppik); Beth Israel Hospital, Boston, Mass (Dr Schachter); and Abbott Laboratories, North Chicago, Ill (Drs Sommerville and Shu). Dr Uthman has received honoraria from Abbott Laboratories for consultations and continuing medical education and has received some reimbursement for travel expenses in connection with the above. Drs Rowan and Schachter have received occasional honoraria from Abbott Laboratories for continuing education presentations. Dr Leppik has received honoraria for serving as a consultant to Abbott Laboratories. Neither they nor any members of their immediate families own any Abbott stock. Drs Sommerville and Shu are full-time employees of Abbott Laboratories.
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