EUCTR2007-001887-55-GB
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BIAL - Portela & Ca, S.A.
- Enrollment
- 304
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Children aged 2 to 18 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 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
Exclusion Criteria
- •Primarily generalised seizures
- •Baseline seizure frequency aubstantially different from usual aeizure frequency
- •Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion)
- •Known second or third degree atrioventricular (AV) block
- •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
Outcomes
Primary Outcomes
Not specified
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