Refractory partial epilepsy
Conditions
Interventions
Product Name: Eslicarbazepine (Acetate)
Product Code: BIA 2-093
Pharmaceutical Form: Tablet
INN or Proposed INN: Eslicarbazepine (Acetate)
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At visit 1 (screening), patient must be/have : 1. Written informed consent signed by patient. 2. Aged 18 years or more. 3. A documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening. 4. At least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening. 5. Currently treated with 1 to 3 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 (a confirmatory test should be available within 1 month before study entry). Vagus nerve stimulation (VNS) is considered an AED (i.e., only up to two concomitant anti-epileptic drugs are allowed in patients with VNS). 6. Excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests. 7. 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) beginning at screening and continuing at least to the post-study visit (PSV). At visit 2 (randomisation), patient must have: 8. At least 4 partial seizures in each 4 weeks during the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 21 consecutive days. 9. In case of woman of childbearing potential, patient must present a urine beta-hCG test consistent with a non-gravid state. 10. Diaries satisfactorily completed by the patient or his/her caregiver. 11. 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
Exclusion criteria
Exclusion criteria: At visit 1 (screening), patients must not be / have: 1. Only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures [Appendix C]) that are not video-EEG documented. 2. Primarily generalised epilepsy. 3. Known rapid progressive neurological disorder. 4. History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening. 5. Seizures of psychogenic origin within the last 2 years. 6. History of schizophrenia or suicide attempt. 7. Currently on or with exposure to felbamate or oxcarbazepine within one month of screening. 8. Using benzodiazepines on more than an occasional basis (except when used chronically as AED). 9. Previous use of BIA 2-093 or participation in a clinical study with BIA 2-093. 10. Known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances. 11. History of abuse of alcohol, drugs or medications within the last 2 years. 12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder. 13. Second or third-degree atrioventricular blockade not corrected with a pacemaker. 14. Relevant clinical laboratory abnormalities (e.g., Na+ 2.0 times the upper limit of the normal, white blood cell count (WBC) <3,000 cells/mm3). 15. Estimated creatinine clearance <50 mL/min [men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL]. 16. Pregnancy or nursing. 17. Participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whatever is longer. 18. Not ensured capability to perform the trial. 19. 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: 20. Inadequate compliance to concomitant AEDs during the 8-week baseline period. 21. Inadequate completion of the study diary. 22. 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: The primary objective of this trial is to evaluate the efficacy of BIA 2-093 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.;Secondary Objective: (1) To evaluate the safety and tolerability of BIA 2-093 at once-daily doses of 400 mg, 800 mg and 1200 mg in comparison to placebo, over a 12-week maintenance period preceded by a 2-week titration period. (2) To evaluate the safety and tolerability of BIA 2-093 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 BIA 2-093 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 interactions between BIA 2-093 and concomitant anti-epileptic drugs 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 double-blind and open-label parts of the study. ;Primary end point(s): Seizure frequency over the 12 week maintenance period. Seizure frequency will be standardised to a “frequency per 4 weeks” period. | — |
Countries
Denmark, Spain, Sweden
Outcome results
None listed