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 TRIAL.
- Conditions
- simple partial seizures with no motor symptomatology EpilepsyMedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy
- Registration Number
- EUCTR2008-002455-25-DE
- Lead Sponsor
- BIAL - Portela & Cª, SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
-At visit 1 (screening), patient must be/have:
*written informed consent signed by patient
*Aged 18 years or more;
*Documented diagnosis of epilepsy for at least 12 months prior to screening
*At least 4 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) on the 4-weeks prior to screening
*Currently treated with 1 or 2 AEDs (any except oxcarbazepine), 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, vagus nerve stimulation [VNS] is considered an AED, i.e., only up to 1 concomitant AED is allowed in patients with VNS); excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination
(PE) and clinical laboratory tests
*Post-menopausal women or female patients otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential (WOCBP), patient must present a serum ß-human chorionic gonadotropin
(ß-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.
-At visit 2 (randomisation), patient must have
*At least 4 partial-onset seizures per 4 weeks during the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 21 consecutive days
*In case of WOCBP, patient must present a urine ß-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-At visit 1 (screening), patients must not be / have:
*Only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures)
*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 nonepileptic origin
*Major psychiatric disorders; seizures of psychogenic origin within the last 2
years
*History of schizophrenia or suicide attempt; currently treated with oxcarbazepine
*Using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
*Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate
*Known hypersensitivity to carbamate 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 laboratoryabnormalities (e.g., Na+ <130 mmol/L, alanine or aspartate transaminases [ALT or AST] >2.0 times the upper limit of the normal [ULN], white blood cell count [WBC] <3,000 cells/mm3)
Estimated creatinine clearance (CLCR) <60 mL/min; pregnancy 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
*Not ensured capability to perform the trial; any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.
-At visit 2 (randomisation), patients must not be / have:
*Inadequate compliance to concomitant AEDs during the 8-week baseline period
*Inadequate completion of the study diary
*Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method