A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Male and female patients aged 18-65 years
Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit
At least 4 seizures per month within the last 2 months prior to randomisation
Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation
Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy)
Written informed consent.

Exclusion Criteria

Patient with nervus vagus stimulation
Patient with primarily generalized seizures
Known progressive neurological disturbance
A history of status epilepticus within the past 3 months
Seizure of non-epileptic origin
Restricted legal competence and incapability to follow trial instructions
Major psychiatric disorders
Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers
Need of excluded concomitant medication (see section 9.4.6.2)
Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit
Known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites
Abuse of alcohol, drugs or medications
History of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders
Second- or third-degree atrioventricular block not corrected with a pacemaker
Relevant laboratory abnormalities (e.g., Na+< 130 mmol/L, alanine (ALT) or aspartate (AST) transaminase >2.0 times the upper limit of normal, white blood cell (WBC) count <3000 cells/mm3)
Pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method)
Participation in other clinical trials within the last 2 months
History of non-compliance.

Arm && Interventions

Group	Intervention	Description
ODG - once-daily group	BIA 2-093	BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
TDG - twice-daily group	BIA 2-093	BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
PLG - placebo group	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period	baseline, week 12

Secondary Outcome Measures