Phase 3
N=395
Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
Partial Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00957047 ↗Enrolled (actual)
395
Serious AEs
5.6%
Results posted
Aug 2013
Primary outcome: Primary: PART I - Seizure Frequency — 7; 8.7; 7.1; 9.8 ln (Seizures) per 4 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- eslicarbazepine acetate (Drug); placebo (Drug); ESL - Part II (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PART I - Seizure Frequency |
7; 8.7; 7.1; 9.8 | — |
| PRIMARY PART II - Nº of Treatment-Emergent Adverse Events (TEAE) |
270; 151; 240; 194; 37; 28 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00957047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.