Status:
COMPLETED
Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Partial Epilepsy
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
Brief 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.
Detailed Description
This will be a 2-part multicentre study in approximately 117 patients. Part I of the study will consist of a 4-week prospective observational baseline period, a 12-week double-blind period (4-week up-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01527513
Start Date
August 1 2010
End Date
May 1 2013
Last Update
October 24 2014
Active Locations (36)
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1
Ospedale Salesi
Ancona, Italy, 60123
2
Ospedale Pediatrico Giovanni XXII
Bari, Italy, 70126
3
Ospedale Maggiore "C.A. Pizzardi"
Bologna, Italy, 40133
4
Istituto Scientifico G. Gaslini
Genova, Italy, 16146