EFFECTS OF ESLICARBAZEPINE ACETATE (BIA 2-093) ON COGNITIVE FUNCTION IN CHILDREN WITH PARTIAL ONSET SEIZURES: AN ADD-ON, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE CLINICAL TRIA

• Conditions: Evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.; MedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy

• Registration Number: EUCTR2008-005606-39-NL
• Lead Sponsor: BIAL-Portela & Ca, SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

At Visit 1 (screening), patient must be / have:
1.Written informed consent signed by parent or legal representative and, where applicable, the patient.
2.Aged 6 to 16 years, inclusive.
3.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.
4.An IQ of at least 70.
5.Current treatment with 1 to 2 AEDs (any except oxcarbazepine, benzodiazepines other than clobazam and VNS).
6.Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
7.In the opinion of the investigator, able to complete the CDR test battery.
8.In case of a girl of childbearing potential, patient presents a serum ß-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 PSV.

At Visit 2 (randomisation), patient must have:
9.At least 2 partial-onset seizures during the 4-week baseline period prior to randomisation (documented in a diary).
10.In case of a girl of childbearing potential, patient presents a urine ß-hCG test consistent with a non-gravid state.
11.Stable dose regimen of concomitant AEDs during the 4 week baseline period.
12.Diaries satisfactorily completed by the patient or his/her caregiver during the baseline period.
13.Satisfactory compliance with the study requirements durign the baseline period.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).
2.Primarily generalised seizures.
3.Known rapidly progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
4.Occurrence of seizures too close together to count accurately.
5.History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
6.Seizures of non-epileptic origin.
7.Lennox-Gastaut syndrome.
8.West syndrome.
9.Major psychiatric disorders.
10.Seizures of psychogenic origin within the last 2 years.
11.History of schizophrenia or suicide attempt.
12.History of attention deficit disorder or other diseases adversely affecting cognitive abilities.
13.Currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a routine or chronic basis) and/or VNS.
14.Known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine).
15.Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
16.Second or third degree atrioventricular blockade.
17.Relevant clinical laboratory abnormalities.
18.Estimated creatinine clearance (CLCR) <60 mL/min.
19.Pregnancy or nursing.
20.Treatment with ESL in any previous study.
21.Participation in other drug clinical trial within the last 2 months.
22.Not ensured capability to perform the trial.
23.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
Main Objective: The primary study objective is to evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.;Secondary Objective: •To evaluate the safety and tolerability of ESL in comparison with placebo, over an 8-week maintenance period preceded by a 4 week titration period and followed by a tapering-off period. <br>•To evaluate the efficacy of ESL compared with placebo as adjunctive therapy in children with refractory partial epilepsy over an 8 week maintenance period. <br>•To evaluate the safety, tolerability and sustainability of the therapeutic effect of ESL during a 1-year open label treatment. <br>;Primary end point(s): Change from baseline to the end of the evaluation period in the composite Power of Attention measure in order to assess information processing speed and attention / psychomotor speed.