An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 98
- 试验地点
- 24
- 主要终点
- To evaluate the efficacy of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after approx 6 weeks of treatment.
研究概览
简要总结
An non controlled, long term, multi center investigation
详细描述
Subjects who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the subjects will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as Baseline for the performance assessments.
A non-controlled, long term, multi-center investigation for symptom improvement in subjects suffering headache and migraine attacks.
During the run-in (baseline) period and through the whole study the subjects will continue using their existing prescribed or over the counter (OTC) treatments.
Following the run-in period (4 weeks) the subjects will be treated six times within a period that is approximately 6 weeks. The first treatment will be given the first day after the run-in period.
During 12-month follow-up period (from the time of the first treatment), subjects will be treated when needed but a maximum of 14 treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION AND
排除标准
- •Inclusion Criteria
- •The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form;
- •Male or female aged between 18 and 70 years (inclusive) at the time of providing informed consent;
- •Diagnosed with chronic migraine with or without aura (≥15 headache days per month including at least 8 migraine days for more than 3 months before screening) according to the International Headache Society classification (International Classification of Headache Disorders III);
- •Migraine onset before the age of 65 years;
- •Reported history of migraine for at least 1 year before screening;
- •Able and willing to maintain current prophylactic migraine medication regimen (if any) (no change in type, frequency or dose) from screening to at least the 6-month follow-up;
- •Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate <1% per year when used consistently and correctly) during the study.
- •Exclusion Criteria
- •Unable to distinguish between migraine headache and other headache types;
- •An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity.
- •Nasal cavity abnormalities that prevents catheter insertion.
- •A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel).
- •A known allergy to polyurethane (polyurethane is used in the catheter balloon).
- •Systemic diseases with manifestations in the nose.
- •Previous treatment with radiation therapy to the nasal area.
- •Nasal surgery performed within the last six months.
- •Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;
- •Pregnant and lactating women;
- •Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
- •Previous participation in this study;
- •Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.
- •Only at baseline visit (day 0) If subject missed >4 days of eDiary entry, subject will be withdrawn.
结局指标
主要结局
To evaluate the efficacy of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after approx 6 weeks of treatment.
时间窗: Baseline to 6 weeks
Change in proportion of days with headache with moderate to severe intensity compared to the four week period starting the day after the third treatment Headache days are collected in electronic diary (eDiary)
次要结局
- To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.(Baseline to 12 month)
- Mean change in Subject global severity(Baseline to 12 month)
- To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.(Baseline to 12 month)
- Number of patients who are responders(Baseline to 12 month)
- Number of patients who decrease use of abortive medication(Baseline to 12 month)
- Mean change in Headache Impact Test (HIT-6)(Baseline to 12 month)