Efficacy Study of Metadoxine SR Formulation in ADHD Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Alcobra Ltd.
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.
详细描述
Primary outcome measure is the safety and tolerability of study drug after a single dosing.
Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.
Exploratory outcome measures include:
- TOVA measures like response time , variability, omissions etc.
- Subtests from Wechsler: digit memory, digit-number signs etc
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-45
- •diagnosed as ADHD
排除标准
- •PDD patients
- •head injured patients
- •patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B
研究组 & 干预措施
Metadoxine SR
Metadoxine is a pyrolate salt of Pyridoxine
干预措施: Extended Release Metadoxine (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 24 hours after drug adminstration
Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug
次要结局
未报告次要终点