EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS ADJUNCTIVE THERAPY FOR REFRACTORY PARTIAL SEIZURES IN A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIA
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0000360
- Lead Sponsor
- BIAL Portela & Ca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Written informed consent signed by patient. A documented diagnosis of epilepsy for at least 12 months prior to screening; at least 4 partial-onset seizures on the 4-weeks prior to screening; currently treated with 1 or 2 AEDs (any except OXC), in a stable dose regimen during at least 1 month prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified, and a confirmatory test should be available within 1 month before study entry): if present, the device for vagus nerve stimulation (VNS) should be implanted at least 6 months before screening, parameters need to be stable for at least 1 month prior to screening (VNS will not be counted as concomitant AED); excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination (PE), and clinical laboratory test results; post-menopausal women or female patients otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of women of childbearing potential (WOCBP), patient must present a serum beta-human chorionic gonadotropin (B-hCG) test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (hormonal contraception should be combined with a barrier method) beginning at screening and continuing at least to the post-study visit or at least until 30 days after last dose of study drug.
at least 8 partial-onset seizures during the baseline with at least 3 partial-onset seizures in each 4-week section of the 8-week baseline period (documented in a diary) and no seizure-free interval exceeding 28 consecutive days; in case of WOCBP, patient must present a urine B-hCG test consistent with a non-gravid state; diaries satisfactorily completed by the patient or his/her caregiver; satisfactorily complied with the study requirements during the baseline period (including no changes in concomitant AED therapy should have occurred in the baseline period).
only simple partial seizures with no motor symptomatology; primarily generalised seizures; known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion); occurrence of seizures too close to count accurately; 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 non-epileptic origin; major psychiatric disorders; seizures of psychogenic origin within the last 2 years; documented diagnosis of schizophrenia with accompanying documented history of at least 1 acute psychosis episode (within the last 2 years) or history of suicide attempt; currently treated with OXC; using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as AED; previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate (patients not exposed to Eslicarbazepine acetate e.g., screen-failed are allowed); known hypersensitivity to carboxamide derivatives; 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 (e.g., sodium <130 mmol/L, alanine or aspartate transaminases >2.0 times the upper limit of normal, white blood cell count <3,000 cells/mm3); estimated creatinine clearance <60 mL/min or for patients of Asian ancestry, positive HLA-B*1502 test; pregnant or nursing; participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whichever is longer, patient(s) who are known to have not taken any doses of study drug(s) in earlier study(ies) (e.g., screen-failures) are allowed without any time limitation; not ensured capability to perform the trial; any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient ability to comply with the study protocol; currently treated with VNS, but implanted >6 months before screening or parameters not stable for at least 1 month prior to screening.
inadequate compliance to concomitant AEDs during the 8-week baseline period or to screening exclusion criteria; inadequate completion of the study diary; any other condition or circumstance that, in the opinion of the Investigator, may compromise the patients ability to comply with the study protocol.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standardised seizure frequency over the 12-week maintenance period. Seizure frequency for all the periods considered during Part I of the study, including the baseline, titration, and maintenance peri
- Secondary Outcome Measures
Name Time Method Safety:Adverse events, clinical laboratory test results, vital sign measurements, body weight, ECG, Medical Outcomes Study Sleep Scale, Suicide Severity Rating Scale, and blood levels of IP and AEDs;Efficacy: Clinical Global Impressions(CGI) - Assessment of each measurement changes which will be summarised by treatment group at baseline and at each assessment timepoint. ;Efficacy: Quality Of Life In Epilepsy inventory-31 (QOLIE-31);Efficacy: Seizure Severity Questionnaire (SSQ) - Assessment of each measurement changes which will be summarised by treatment group at baseline and at each assessment timepoint. ;Efficacy: Montgomery Asberg Depression Rating Scale (MADRS) - Assessment of each measurement changes which will be summarised by treatment group at baseline and at each assessment timepoint.