EUCTR2012-001091-11-HR进行中（未招募）1 期
OPEN-LABEL, 2-DOSE LEVEL TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (ESL) AS ADJUNCTIVE THERAPY IN INFANTS WITH REFRACTORY EPILEPSY WITH PARTIAL-ONSET SEIZURES AGED FROM 1 MONTH TO <2 YEARS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- 性别
- All
入选标准
- •1. Have an informed consent signed by their parent(s) or guardian(s) before undergoing any study-related activities.
- •2. Male or female =1 month (i.e. at least 28 days) but <2 years of age.
- •3. Weigh a minimum of 4 kg at Visit 1.
- •4. Epilepsy refractory to treatment with 1 to 2 AEDs and with clinical or electroencephalogram (EEG) evidence of partial onset seizures for at least 1 month in infants =6 months of age, or for at least 2 weeks in infants <6 months of age, as defined by the International League Against Epilepsy. In case a child has a significant birth defect, hydrocephalus, or tetraparesis, EEG confirmation must be available.
- •5. Current treatment with 1 to 2 AEDs (except OXC; vagus nerve stimulation if present and functioning will not be counted as an AED).
- •6. Ability to come to the study site every day during the Titration/Evaluation Periods.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •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
排除标准
- •1. A neonate who is a preterm baby (i.e. born before 36 weeks of gestation).
- •2. Diagnosis of treatable seizure aetiology such as metabolic, toxic, and infectious disorders.
- •3. Primarily generalised seizures.
- •4. Known rapidly progressive neurological disorders (e.g. rapidly progressive brain disease, epilepsy secondary to rapidly progressive cerebral lesion).
- •5. History of status epilepticus or cluster seizures (i.e. 3 or more seizures within 30 minutes) within the month prior to screening.
- •6. Seizures of non-epileptic origin.
- •Ohtahara syndrome, West syndrome [current], Dravet’s syndrome, or Lennox-Gastaut syndrome).
- •8. Difficult venous access.
- •9. Ketogenic diet.
- •10. Currently treated with OXC (at Screening or for at least 2 weeks before).
- •11. Previous use of ESL.
- •12. An AED that started or was discontinued in the 3 weeks before Visit 1.
- •13. Diseases that can have an impact on drug absorption (e.g. any disease leading to diarrhoea or vomiting).
- •14. Treatments that can have an impact on blood volume (e.g. transfusions or intravenous infusions).
- •15. Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, OXC), or to any of the excipients, in particular methyl parahydroxybenzoate (E218) or sulphites.
- •16. Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorders.
- •17. Relevant clinical laboratory abnormalities (e.g. sodium <130 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (measured at Visit 1).
- •18. Estimated glomerular filtration rate below the lower limit of the normal range (measured at Visit 1).
- •19. Participation in other drug clinical trial within the last 2 months or having received an IMP within 5 half-lives of that IMP, whichever is longer.
- •20. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
研究者
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