Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who complete Part I may enter a 1-year open-label extension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• written informed consent signed by patient

• aged 18 years or more

• documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening

• at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)

• excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests

• post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method

Exclusion Criteria:

• only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented

• primarily generalised epilepsy

• known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening

• seizures of psychogenic origin within the last 2 years

• history of schizophrenia or suicide attempt

• currently on or with exposure to felbamate or oxcarbazepine more within one month of screening

• using benzodiazepines on more than on an occasional basis (except when used chronically as AED)

• previous use of ESL or participation in a clinical study with ESL

• known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances

• history of abuse of alcohol, drugs or medications within the last 2 years

• uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder

• second or third-degree atrioventricular blockade not corrected with a pacemaker

• relevant clinical laboratory abnormalities