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