Status:
COMPLETED
Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Refractory Partial Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group, randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks double-blind titration...
Detailed Description
Duration of Treatment: The duration of Part I was 26 weeks: 8 weeks of placebo run-in, 2 weeks of dose titration, 12 weeks of maintenance, and 4 weeks of tapering-off period. The duration of Part II w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00957684
Start Date
July 1 2004
End Date
February 1 2007
Last Update
March 12 2025
Active Locations (1)
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1
Bial - Portela & Cª, S.A.
São Mamede do Coronado, Portugal, 4745-457