NCT00219245已完成4 期
A 26-Week Open-Label Extension to Protocol No. CENA713BUS11: A 12-Week, Prospective, Double-blind, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Rivastigmine 3 to 6 mg/Day in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 157
- 主要终点
- Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
研究概览
简要总结
Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a deficit in the areas of attention and/or memory.
- •Have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury;
- •Be at least 12 months post brain injury;
排除标准
- •A history of a major brain surgery;
- •A penetrating brain injury (e.g., gun shot wound);
- •A current diagnosis of epilepsy;
- •Had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis);
- •Previous exposure to rivastigmine.
结局指标
主要结局
Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment
次要结局
- Changes in cognitive functioning from baseline to week 26
- Changes in behavior from baseline to week 26
- Changes in depression from baseline to week 26
- Changes in quality of life from baseline to week 26
- Changes in overall functioning from baseline to week 26
研究者
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