EUCTR2006-003359-19-NL进行中（未招募）1 期
An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome - N.A.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •Children with Down syndrome, genetically cariotyped with trysomy 21, meiotic non-disjunction
- •Subjects aged between 9 - 16 years
- •Subjects naive to any cholinerg drug
- •Subjects of childbearing potential must have a negative serum beta-hcg pregnancy test and must use a reliable contraceptive
- •Subjects should have sufficiently developed language and memory skills to perform neurocognitive tests
- •Subjects and/or parents should have provided informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Known hypersensitivity to galantamine hydrobromide or any excipients used in the formulation
- •history of severe drug allergy or hypersensitivity
- •weight/height below the 5th percentile for age on the standardized curve for subjects with Down syndrome
- •Trisomy 21, mosaic (mitotic non-disjunction)
- •Trisomy 21, translocation
- •subject having received prohibited medication
- •history or presence of one of the specified conditions possibly resulting in cognitive impairment
- •Current clinically significant cardiovascular disease, gastrointestinal disease, psychiatric disease, uncorrected hearing or visual disturbances, hepatic, renal or pulmonary disturbances, urinary outflow obstructions,
- •History of epilepsy, malignancy
研究者
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