NCT00800514撤回不适用
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the Interval Bisection Timing Task.
研究概览
简要总结
The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task. Approximately 16 individuals with traumatic brain injury are expected to participate in this study. Subject participation is expected to last up to 8 weeks with 16 study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 55 inclusive. History of post-MVA close head TBI. Female subjects must use an acceptable method of contraception during entire study. Acceptable methods of contraception are: history of surgical sterility, postmenopausal status, hormonal contraceptives, or accepted barrier devices (i.e., male/female condom, diaphragm, cervical cap, intrauterine device).
排除标准
- •Current or past history of major psychiatric disorder (schizophrenia, bipolar disorder, major depressive disorder)
- •Substance use disorder
- •Current or past history of serious chronic medical condition (pulmonary (lung), cardiovascular (heart), hepato-renal (liver-kidney) disease, diabetes)
- •Smoking one or more packs of cigarettes per day
- •If you are pregnant or breastfeeding, or plan to become pregnant during the study
研究组 & 干预措施
active
Experimental
干预措施: amantadine (Drug)
结局指标
主要结局
The primary outcome measure is the Interval Bisection Timing Task.
时间窗: 12 -16 months
次要结局
- The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).(12-16 moths)
研究者
研究点 (1)
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