Eficacia y seguridad del acetato de eslicarbazepina (BIA 2-093) como terapia adyuvante para crisis parciales refractarias en niños: estudio clínico doble ciego, aleatorizado, comparado con placebo, de grupos paralelos y multicéntrico.Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as adjunctive therapy for refractory partial seizures in children: a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial

Phase 1

• Conditions: iños y adolescentes con crisis epilépticas parciales refractarias. children and adolescents with refractory partial epileptic seizures.; MedDRA version: 9.1Level: PTClassification code 10015037Term: Epilepsy

• Registration Number: EUCTR2007-001887-55-ES
• Lead Sponsor: BIAL - Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-05
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Inclusion criteria
? Children aged 2 to 16 years
? Diagnosis of epilepsy for at least 6 months prior to enrolment
? At least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
? At least 4 partial-onset seizures during each 4 week interval of the 8 week baseline period
? previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
? Current treatment with 1 or 2 AEDs (any AED except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
? Stable dose regimen of AEDs during the 8 week baseline period
? Cooperation and willingness to complete all aspects of the study, including hospitalisation if required
? Written informed consent to participate in the study in accordance with local legislation
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

? Primarily generalised seizures
? Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion)
? History of status epilepticus within the 3 months prior to enrolment
? Seizures of non-epileptic origin (e.g. metabolic or neoplastic, or related to active infection)
? Lennox-Gastaut syndrome
? West syndrome
? Major psychiatric disorders
? Previous treatment in any study with eslicarbazepine acetate
? Participation in a clinical trial within the last 2 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified