Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate

Criteria

Inclusion Criteria:

At visit 1 (screening), patient must be/have:

• written informed consent by parent or legal guardian and, where applicable, the patient;

• age 6 to 16 years, inclusive;

• a documented diagnosis of epilepsy for at least 12 months prior to screening;

• at least 2 partial onset seizures during the 4 weeks prior to screening despite treatment with 1 to 2 AEDs in a stable dose regimen;

• an Intelligence Quotient (IQ) of at least 70;

• current treatment with 1 to 2 AEDs (except oxcarbazepine, benzodiazepines other than clobazam and vagus nerve stimulation (VNS));

• excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and clinical laboratory tests;

• in the opinion of the investigator, able to complete the Cognitive Drug Research (CDR) test battery;

• in case of a girl of childbearing potential, patient presents a serum B-human chorionic gonadotropin (B hCG) test consistent with a non gravid state and agrees to remain abstinent or use reliable contraception (if used, hormonal contraception must be combined with a barrier method) starting at screening and continuing until at least the post-study visit (PSV).

At visit 2 (randomisation), patient must be/have:

• at least 2 partial-onset seizures during the 4 week baseline period prior to randomisation (documented in a diary);

• in case of a girl of childbearing potential, patient presents a urine B-hCG test consistent with a non-gravid state;

• stable dose regimen of concomitant AEDs during the 4 week baseline period;

• diaries satisfactorily completed by the patient or his/her caregiver during the baseline period;

• satisfactory compliance with the study requirements during the baseline period.

Exclusion Criteria:

At visit 1 (screening), patients must not be/have:

• only simple partial seizures with no motor symptomatology;

• primarily generalised seizures;

• known rapidly 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;

• Lennox-Gastaut syndrome;

• West syndrome;

• major psychiatric disorders;

• seizures of psychogenic origin within the last 2 years;

• history of schizophrenia or suicide attempt;

• history of attention deficit disorder or other diseases adversely affecting cognitive abilities;

• currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a routine or chronic basis) and/or VNS;

• known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine);

• uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder;

• second or third degree atrioventricular blockade;

• relevant clinical laboratory abnormalities;

• estimated creatinine clearance (CLCR) <60 mL/min;

• pregnancy or nursing;

• treatment with eslicarbazepine acetate in any previous study;

• participation in other drug clinical trial within the last 2 months;

• 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:

• any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.