simple partial seizures with no motor symptomatology Epilepsy MedDRA version: 9.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
Conditions
Interventions
Product Name: ESLICARBAZEPINE ACETATE
Product Code: BIA 2-093
Pharmaceutical Form: Tablet
INN or Proposed INN: Eslicarbazepine acetatep
Current Sponsor code: BIA 2-093
Other descriptive name: (S)-10-a
Sponsors
BIAL - Portela & Cª, SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -At visit 1 (screening), patient must be/have: *Written informed consent signed by patient and by parents or legal guardian if the patient is an adolescent between 16_18 years old, and written assent form signed by the adolescent *Aged 16 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? yes 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
Exclusion criteria
Exclusion criteria: -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+ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Eslicarbazepine acetate QD at doses of 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.;Secondary Objective: (1) To evaluate the safety and tolerability of Eslicarbazepine acetate at QD doses of 800 mg and 1200 mg in comparison with placebo, over a 12-week maintenance period preceded by a 2-week titration period. (2) To evaluate the safety and tolerability of Eslicarbazepine acetate at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. (3) To assess the maintenance of therapeutic effects of Eslicarbazepine acetate over a 12-week maintenance period preceded by a 2-week titration period, and over a 1-year open-label period. (4) To assess the drug-drug pharmacokinetic (PK) interactions between Eslicarbazepine acetate and concomitant anti-epileptic drugs (AEDs) over the double-blind and open-label parts of the study. (5) To assess the health-related quality-of-life and depressive symptoms over the doubleblind and open-label parts of the study;Primary end point(s): Change of seizure frequency over the 12-week maintenance period as compared with the 8-week baseline period. Seizure frequency for all the periods considered, including the maintenance and baseline periods, will be standardised to a “frequency per 4 weeks” basis. | — |
Countries
Cyprus, France, Germany, Greece, Hungary, Italy, Romania
Outcome results
None listed