EUCTR2017-001514-29-Outside-EU/EEA进行中（未招募）1 期
A multi-center, uncontrolled, open-label, evaluation of Lamotrigine monotherapy on newly diagnosed typical absence seizures in children and adolescents - Open study of Lamictal monotherapy for children with absence seizures
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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. Target disease: Subjects with newly diagnosed and untreated typical absence seizure which is classifiable by the International Classification of Seizures.
- •2. Diagnosis of typical absence seizures is established by at least one of two 4-minute hyperventilation tests as supported by clinical signs and EEG findings.
- •The following criteria will be used to define a typical absence seizure on the EEG: a discharge of generalized spike-and-wave or multiple spike-and-wave activity lasting =3 seconds during the awake state. The frequency of the spike-and-wave should be between 2.5-4.5 Hz.
- •3. Age (at the time of obtaining consent):
- •2 to 15 years of age in Japan
- •2 to 12 years of age in South Korea
- •4. Subjects must weigh at least 7 kg
- •5. Outpatients
- •6. Parent/guardian must have given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent.
- •7. Gender: Male or female
- •8. QTc<450 millisecond (msec) or <480msec for subjects with Bundle Branch Block – values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •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. Subjects with partial seizure or generalized seizures other than typical absence.
- •2. Subjects with a history of rash associated with other treatment.
- •3. Subjects with any clinically significant chronic cardiac, renal, or hepatic medical condition. Any patient with these conditions will be excluded from the study even if these conditions are being controlled with chronic therapy.
- •4. Subjects with an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or with any unstable physical symptoms likely to require hospitalization during participation in the study.
- •5. Subjects with a psychiatric disorder requiring medication, or who had psychiatric conditions in the past that was both judged to be severe and required hospitalization.
- •6. Subjects with an acute or progressive neurological disorder or an organic disease.
- •7. Subjects with currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
- •8. Subjects with an unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •9. Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study.
- •10. Children in foster care: A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian.
- •11. Subjects taking inducers of lamotrigine glucuronidation (i.e., rifampicin, lopinavir/ritonavir), atazanavir/ritonavir, risperidone, oral contraceptives or hormone drug which includes estrogen.
- •12. Subjects having participated in other clinical study in the past 3 months before the start of investigational product.
- •13. Subjects who have active suicidal plan/intent or have had active suicidal thoughts in the past 3 months before the start of investigational product or who have history of suicide attempt in the last 1 year before the start of investigational product or more than 1 lifetime suicide attempt.
- •14. Subjects whom the investigator (or subinvestigator) considers ineligible for the study.
研究者
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