An Open Pilot Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine on Patients Not Responding to a Preventive Treatment Targeting the CGRP Pathway
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Mean change in headache days
研究概览
简要总结
An open pilot study, non-controlled, single center investigation.
详细描述
An open pilot study, non-controlled, single center investigation. The study consists of a 4-week screening period, a 6-week treatment period, and a 12 week follow-up period.
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.
Subjects who completed the screening period and continue to meet the eligibility criteria after review of diary entries by the investigator will receive treatment. The subjects will receive 6 treatments with the Chordate System S220 at weekly intervals at the site (Day 0 to 35; treatment Visit [V] 1 to 6) and continue to maintain a daily diary.
After completion of the 6-week study treatment period (V1 to V6), subjects will be treated monthly and followed up for another 12 weeks. The final visit will be performed on Day 125, 12 weeks after the last study treatment. During the 12-week follow-up, the subjects will continue to complete a daily diary.
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
- •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 as suffering from 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 50 years.
- •Reported history of migraine for at least 1 year before screening.
- •If subjects are on a preventive treatment at the time of screening, this must have been stable over the preceding 3 months.
- •If subjects are on preventive treatment at the time of screening, they have to be able and willing to maintain current preventive treatment regimen (no change in type, frequency or dose) from screening to end of follow-
- •Failed at least 3 different preventive medications and 3 months of treatment with a CGRP targeting therapy.
- •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.
排除标准
- •Unable to distinguish between migraine 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;
结局指标
主要结局
Mean change in headache days
时间窗: baseline to 6 weeks
Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary
次要结局
- Mean change in Hospital Anxiety and Depression Scale (HADS)(baseline to 12 weeks)
- Number of patients who decrease use of abortive medication(baseline to 12 weeks)
- Mean change in headache days(week 6-12)
- Incidence of adverse events (AEs) and adverse device effects (ADEs)(Baseline to 12 weeks)
- Mean change in Migraine days Mean change of migraine days, responder rate, use of abortive medication, health-related quality of life and disability, and patient's global impression of severity 12 weeks (90 days)(Baseline to 12 weeks)
- Number of patients who are responders(baseline to 12 weeks)
- Mean change in Headache Impact Test (HIT-6)(baseline to 12 weeks)
- Mean change in Subject global severity(baseline to 12 weeks)