Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Mean Percentage of Headache Days
研究概览
简要总结
This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.
详细描述
Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
- •Suffer at least fifteen total headache days per month
- •Ability to speak and read English
排除标准
- •Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
- •Previous use of OnabotulinumtoxinA for treatment of headache
- •Any medications commonly used as headache preventives started less than 3 months prior to enrollment
- •Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
- •Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
- •Subjects who are pregnant or trying to become pregnant within the timeframe of the study
研究组 & 干预措施
Treatment with OnabotulinumtoxinA
OnabotulinumtoxinA
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Change in Mean Percentage of Headache Days
时间窗: Baseline, 9 months
To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).
次要结局
- Change in MIDAS Score(Baseline and 9 month.)
- Change in HIT-6 Score.(Baseline and 9 month.)
- Change in SF-36 Assessment Scores(Baseline and 9 month.)
研究者
Sylvia Lucas
Clinical Professor
University of Washington