Melatonin Studies of Blind Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
研究概览
简要总结
The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.
详细描述
We intend to study as many as 26 blind children through up to three melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 3 treatment plans differ only in the start dose. Successfully treated subjects (of one treatment plan) will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults 5 to 20 years old
- •Blindness for at least one year, verified by an ophthalmologic exam
- •Ability to comply with the requirements of the experimental protocol
- •And no clinically significant abnormalities (other than blindness) on a general physical examination.
- •Subjects must be competent to sign informed consent if age 18 or older. Parents and subjects will be interviewed together and, when appropriate (for example, subject is age 18 or older), separately as well.
排除标准
- •Abnormal heart, liver or kidney function; intractable seizure disorders
- •Significant laboratory abnormalities on CBC, Comprehensive Metabolic set, or UA (dip stick method)
- •Pregnancy; sexual activity in post-pubertal females not using a recognized and valid contraceptive method
- •A current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual ; OR
- •External demands that limit the ability to maintain a regular schedule, e.g. night shift work.
结局指标
主要结局
Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
时间窗: biweekly throughout the entire study
次要结局
- Durability and Toxicity Side Effects Questionnaire(1 year)