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: MedDRA version: 9.1Level: PTClassification code 10015037Term: Epilepsy; children and adolescents with refractory partial epileptic seizures

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-10
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 304

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
• Current treatment with 1 or 2 AEDs (any AED except oxcarbazepine)
• 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

Study & Design

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