Tiagabine therapy for complex partial seizures

A dose-frequency study

Rajesh C. Sachdeo, Robert F. Leroy, Gregory Krauss, Miles E. Drake, Philip M. Green, Ilo E. Leppik, Vincent S. Shu, Gary L. Ringham, Kenneth W. Sommerviile

Research output: Contribution to journalArticle

Abstract

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, placebo-controlled, 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.

Original languageEnglish (US)
Pages (from-to)595-601
Number of pages7
JournalArchives of Neurology
Volume54
Issue number5
StatePublished - 1997

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Seizures
Placebos
Therapeutics
tiagabine
Dose
Therapy
Anticonvulsants
Epilepsy
Central Nervous System
Outcome Assessment (Health Care)
Placebo
Safety
Drug Therapy

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Sachdeo, R. C., Leroy, R. F., Krauss, G., Drake, M. E., Green, P. M., Leppik, I. E., ... Sommerviile, K. W. (1997). Tiagabine therapy for complex partial seizures: A dose-frequency study. Archives of Neurology, 54(5), 595-601.

Tiagabine therapy for complex partial seizures : A dose-frequency study. / Sachdeo, Rajesh C.; Leroy, Robert F.; Krauss, Gregory; Drake, Miles E.; Green, Philip M.; Leppik, Ilo E.; Shu, Vincent S.; Ringham, Gary L.; Sommerviile, Kenneth W.

In: Archives of Neurology, Vol. 54, No. 5, 1997, p. 595-601.

Research output: Contribution to journalArticle

Sachdeo, RC, Leroy, RF, Krauss, G, Drake, ME, Green, PM, Leppik, IE, Shu, VS, Ringham, GL & Sommerviile, KW 1997, 'Tiagabine therapy for complex partial seizures: A dose-frequency study', Archives of Neurology, vol. 54, no. 5, pp. 595-601.
Sachdeo RC, Leroy RF, Krauss G, Drake ME, Green PM, Leppik IE et al. Tiagabine therapy for complex partial seizures: A dose-frequency study. Archives of Neurology. 1997;54(5):595-601.
Sachdeo, Rajesh C. ; Leroy, Robert F. ; Krauss, Gregory ; Drake, Miles E. ; Green, Philip M. ; Leppik, Ilo E. ; Shu, Vincent S. ; Ringham, Gary L. ; Sommerviile, Kenneth W. / Tiagabine therapy for complex partial seizures : A dose-frequency study. In: Archives of Neurology. 1997 ; Vol. 54, No. 5. pp. 595-601.
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abstract = "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, placebo-controlled, 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.",
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AU - Sachdeo, Rajesh C.

AU - Leroy, Robert F.

AU - Krauss, Gregory

AU - Drake, Miles E.

AU - Green, Philip M.

AU - Leppik, Ilo E.

AU - Shu, Vincent S.

AU - Ringham, Gary L.

AU - Sommerviile, Kenneth W.

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N2 - 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, placebo-controlled, 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.

AB - 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, placebo-controlled, 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.

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