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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 in Controlling Refractory Partial Seizures When Added to Ongoing Therapy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: BIA 2-093
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODG - once-daily group<br>BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). | Drug: BIA 2-093<br>* BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route<br>|
| Experimental: TDG - twice-daily group<br>BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). | Drug: BIA 2-093<br>* BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route<br>|
| Placebo Comparator: PLG - placebo group<br>placebo | Drug: Placebo<br>* Placebo tablets administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, BIA 2-093