NL-OMON30535撤回不适用
An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome - GAL-PED-1001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Children with Down syndrome, genetically cariotyped with trysomy 21, meiotic non-disjunction, aged between 9 - 16 years, naive to any cholinerg drug, if subject is of childbearing potential she must have a negative serum beta-hcg pregnancy test and must use a reliable contraceptives, and subjects (if > 11 years of age) and parents should have provided informed consent
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
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