Conditions: Epilepsy
Keywords: Anticonvulsant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: yes

Brief summary:
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers

Detailed description:
Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data.

Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.

Arms:
arm 1: 3 tablets of BIA 2-093 600 mg arm 2: 4 tablets of BIA 2-093 600 mg arm 3: placebo tablets

Interventions: intervention 1: BIA 2-093 - 1800 mg (Group 1) intervention 2: BIA 2-093 - 2400 mg (Group 2) intervention 3: Placebo
Intervention descriptions: intervention 1: 3 tablets of BIA 2-093 intervention 2: 4 tablets of BIA 2-093 600 mg intervention 3: placebo tablets

Protocol document: