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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate

Criteria

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.