Conditions: Epilepsy
Keywords: Epilepsy BIA 2-093
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 144
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

Detailed description:
This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Arms:
arm 1: BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). arm 2: BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). arm 3: placebo

Interventions: intervention 1: BIA 2-093 intervention 2: Placebo
Intervention descriptions: intervention 1: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route intervention 2: Placebo tablets administered orally

Protocol document: