A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Placebo
Intervention description: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route; Placebo tablets administered orally
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; BIA 2-093

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.
    

Eligibility 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.