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
- Conditions
- children and adolescents with refractory partial epileptic seizuresMedDRA version: 9.1 Level: PT Classification code 10015037 Term: Epilepsy
- Registration Number
- EUCTR2007-001887-55-GB
- Lead Sponsor
- BIAL - Portela & Ca, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 304
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
Patients participating in the second extension period (Part III) must have/be:
• An additional written informed consent form signed by patient’s parent(s)/guardian and an assent form signed by patients 7 years and older (as described in Section 12.3 of the protocol)
• Ongoing treatment with Eslicarbazepine Acetate in the dose range from 10 mg/kg/day to 30 mg/kg/day (maximum 1200 mg/day)
Patients participating in the third extension period (Part IV) must have/be:
• An additional written informed consent form signed by patient or by patient’s parent(s)/guardian and an assent form signed by patients 7 years and older (as described in Section 12.3 of the protocol)
• Ongoing treatment with Eslicarbazepine Acetate in the dose range from 10 mg/kg/day to 30 mg/kg/day (maximum 1200 mg/day)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
• 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
• Pregnancy
• Breast-feeding
• History of hypersensitivity to the investigational products or to drugs with similar chemical structures
• Impaired renal function, as shown by creatinine clearance values <60mL/min at screening
• Any other clinically significant abnormal laboratory finding at screening
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• Inadequate completion of the study diaries during the baseline period
• Inadequate completation with study requirements during the baseline period
• Participation in a clinical trial within the last 2 months
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