EUCTR2007-001887-55-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
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