Optical Treatment of Migraines Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Headache Impact Test (HIT-6) total score
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.
详细描述
Avulux™ is intended to decrease the impact of headache and migraine on normal daily life and the ability to function, and reduce the frequency and severity of headache, in adult patients diagnosed with episodic migraine headache or chronic migraine.
Avulux™ consists of a pair of optical filters in the form of spectacle lenses, provided in standard spectacle frames or as clip-on units, coated with a thin film that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The active and sham lenses will have tints calibrated such that the optical density, that is the overall "darkness" of all study lenses, will be the same. All study lenses will appear to have the same overall light-blocking effect to study subjects.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years or older
- •Patient is willing and able to provide written informed consent
- •Patient is willing and able to complete all scheduled study visits
- •Diagnosis of migraine, based on the following primary headache characteristics:
- •At least 5 attacks fulfilling criteria b-d:
- •Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- •Headache has at least two of the following characteristics:
- •unilateral location
- •pulsating quality
- •moderate or severe pain intensity
- •aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
- •During headache at least one of the following:
- •nausea and/or vomiting
- •photophobia and phonophobia
- •Not attributed to another disorder
排除标准
- •Patients with other light sensitive conditions, such as iritis.
- •Patients who have less than 4 headache days per month
- •Patients who have chronic daily headaches.
- •Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.
结局指标
主要结局
Headache Impact Test (HIT-6) total score
时间窗: Three-week
The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6) scores at three weeks when compared to a control/sham device. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact.
次要结局
- Number and Severity of Headache Days(Three-week)