Eslicarbazepine Acetate (BIA 2-093) as Therapy for Refractory Partial Seizures in Childre

Phase 1

• Conditions: children and adolescents with refractory partial epileptic seizures; MedDRA version: 14.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-10
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

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

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

Patients participating in the second extension period (Part III) 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 (or 800 mg/day to maximum 1200 mg/day for patients with high body weight)

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 (or 800 mg/day to maximum 1200 mg/day for patients with high body weight)

Patients participating in the 2-year extension period (Part V) 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 (or 800 mg/day to maximum 1200 mg/day for patients with high body weight)

Are the trial subjects under 18? yes
Number of subjects for this age range: 230
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
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 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 hypersensitiviti 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