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 - ND
- Conditions
- refractory partial seizuresMedDRA version: 9.1Level: LLTClassification code 10040703Term: Simple partial seizures
- Registration Number
- EUCTR2007-001887-55-IT
- Lead Sponsor
- BIAL - PORTELA & C, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 315
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 Baseline seizure frequency substantially different from usual seizure frequency 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method