Retrospective, Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Efficacy of Nerivio during menstrual migraines
研究概览
简要总结
Post-marketing, retrospective, observational survey study. Users (menstruating women only) of Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. Eligible users will sign an informed consent form (the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page) and complete a survey asking about their satisfaction with Nerivio and the effectiveness and safety of the device for acute treatment of menstrual migraine. During the survey, participants will be screened to verify that they have menstrual migraine (self-reported) and have used Nerivio to treat menstrual migraines.
详细描述
This study aims to evaluate the safety and efficacy of Nerivio for the acute treatment of menstrual migraine (pure menstrual migraine or menstrually-related migraine).
Up to 500 US-based adults aged 18-55 years old who have been prescribed the Nerivio device and have used it at least 4 times between October 2019 and December 2020.
Informed consent must be obtained from the participant before any protocol-related activities are performed. The consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page.
Users of Nerivio whose details are in the sponsor's database will be contacted by email (provided by the patient during the sign-up process in the Nerivio app required to use the device) and/or through an app notification and will be asked to complete a 5-minute online survey assessing satisfaction, effectiveness, and safety. Participants will sign an informed consent form which will appear as the first page of the survey using open-ended questions, multiple choice questions and Likert scales. Participants will be directed to provide honest opinions regarding the device use for menstrual migraine. No additional information will be collected, and no medical records will be used in this investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-55 years
- •Participants have used Nerivio at least 4 times
- •Participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported)
- •Participants have used Nerivio to treat menstrual migraine
排除标准
- •Non-menstruating women
结局指标
主要结局
Efficacy of Nerivio during menstrual migraines
时间窗: 3 months
Efficacy of Nerivio for headache relief during menstrual migraines rated on a 5-point Likert scale (1 - Not at all effective, 2 - Slightly effective, 3 - Moderately effective, 4 - Very effective, 5- Extremely effective)
Satisfection of using Nerivio during menstrual migraines
时间窗: 3 months
Satisfection of using Nerivio during menstrual migraines rated on a 5-point Likert scale )1 - Not at all satisfied, 2 - Slightly dissatisfied, 3 - Neutral, 4 - Slightly satisfied, 5 -Extremely satisfied)
次要结局
- Mean headache relief(3 months)
- Medication consumption(3 months)
- Reduction of menstrual cramps(3 months)