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Tiagabine therapy for complex partial seizures. A dose-frequency study. The Tiagabine Study Group
R C Sachdeo1, R F Leroy, G L Krauss
1Department of Neurology, University of Medicine and Dentistry of New Jersey, New Brunswick 08901-2160, USA.
Archives of Neurology
|May 1, 1997
Summary
Tiagabine effectively reduced complex partial seizures (CPSs) in patients with refractory epilepsy. Both 2-times-daily and 4-times-daily regimens were well-tolerated, showing significant seizure reduction compared to placebo.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Epilepsy is a neurological disorder characterized by recurrent seizures.
- Complex partial seizures (CPSs) often require add-on pharmacotherapy when initial treatments fail.
Purpose of the Study:
- To assess the efficacy and safety of two tiagabine dosing regimens as adjunctive therapy for refractory CPSs.
- To compare tiagabine's effectiveness against placebo in a randomized, double-blind trial.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 318 patients with refractory CPSs.
- Patients received either tiagabine (16 mg BID or 8 mg QID) or placebo for 12 weeks.
- The primary outcome measure was the change in 4-week CPS frequency from baseline.
Main Results:
- Tiagabine significantly reduced seizure frequency compared to placebo (P=.02 for 16mg BID, P=.06 for 8mg QID).
- A 50% or greater seizure reduction was achieved in 31% (16mg BID) and 27% (8mg QID) of patients, versus 10% for placebo (P<.001).
- Adverse events, primarily CNS-related, were comparable across groups, with similar discontinuation rates.
Conclusions:
- Tiagabine, as add-on therapy, is effective in reducing CPS frequency in treatment-refractory epilepsy.
- Both tested tiagabine regimens demonstrated good tolerability and safety profiles.