Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
研究概览
简要总结
The purpose of this research is to assess how well the Avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.
详细描述
Avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with episodic migraine headaches. In this study, the investigative Avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye 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.
The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
In this study, the investigative Avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye 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.
The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18 years or older
- •Subject is willing and able to provide written informed consent
- •Diagnosis of migraine, based on a history of at least 5 attacks per month with the following primary headache characteristics:
- •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 (e.g. walking or climbing stairs)
- •Headache occurs with at least one of the following symptoms:
- •nausea and/or vomiting
- •photophobia and phonophobia
- •Subject has experienced at least 4 migraine attacks in the last month, with at least two migraine attacks resulting in severe pain prior to the use of any abortive medications
- •Migraines are not attributed to another disorder
排除标准
- •Subjects participating in another prospective, interventional clinical study
- •Subjects with other light sensitive conditions, such as iritis
- •Subjects who have less than 4 headache days per month with the above characteristics
- •Chronic migraine subjects (defined as subjects who experience a minimum of 15 headache days per month)
- •Subjects with headaches due to medication overuse (defined as regular use of headache medication for a minimum of 10 days per month, for a minimum period of 3 months)
- •Subjects who have had any change in their migraine treatment within 4 weeks prior to study enrollment
- •Subjects whose family members are currently participating in this study, or are employees of the study site, Avulux, or the coordinating CRO
结局指标
主要结局
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
时间窗: from baseline to 2 hours after device application
Change in migraine pain from baseline to 2 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
次要结局
- Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)(from baseline to four hours after device application)