A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 8
- 主要终点
- Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
研究概览
简要总结
The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine.
详细描述
This was a prospective, interventional, randomized, placebo-controlled, double-blind, multi-center clinical investigation of a medical device system.
A pilot study in which patients with frequent migraine attacks received intranasal KOS or placebo using the Chordate System S200 on two occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
A placebo module, with one input and 6 outputs, was added to the Chordate S200 system. Some outputs delivered active treatment and others placebo. The operator received a coded envelope and according to that, either active treatment or placebo was selected. The operator did not know which outputs delivered treatment and which did not.
入排标准
- 年龄范围
- 18 Years 至 65 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 (ICF).
- •Male or female aged between 18 and 65 years
- •Diagnosed as suffering from migraine with or without aura according to International Headache Society´s (IHS) classification (International Classification of Headache Disorders (ICHD), 3rd edition, beta version)
- •Reported history of 3 to 8 migraine episodes per month during previous 2 months, confirmed during baseline
- •Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during baseline
- •Onset of migraine headache occurred before age 50
- •Reported history of migraine for more than one year
- •Reported stable dose of prophylactic migraine medication(s), if any, during the two months prior to screening (visit 1), and willing and able to maintain stable dose(s) until the three months follow-up (visit 4)
排除标准
- •Meeting the ICHD criteria for medication overuse
- •Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during baseline
- •Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during baseline
- •Unable to distinguish between migraine headaches and other headache types
- •Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visits
- •Ongoing treatment with implanted stimulator or other implanted device in the head and/or neck region
- •Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds
- •History of sinus surgery, transphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea
- •Fitted with a pacemaker/defibrillator
- •Previously treated with therapeutic radiation to the face (that could have influenced the nasal mucosa)
- •Ongoing upper respiratory tract infection or a body temperature >38.5°C (at treatment), or malignancy in the nasal cavity
- •History of regular nose bleeding (epistaxis), or concomitant condition that could cause excessive bleeding, including treatment with the anticoagulant Varan
- •Head injury or open wound that contraindicates use of Chordate Headband
- •Known allergy to polyvinylchloride, a material used in the Catheter, or medicinal liquid paraffin
- •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
- •Any change in migraine prophylaxis the previous two months
- •Pregnant women
- •Participation in a clinical research study within three months of enrolment or planned participation at any time during this clinical investigation
- •Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members or any such individuals
- •Headache or migraine episode within the 48 hours prior to the first treatment
结局指标
主要结局
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
时间窗: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
次要结局
- Responder Rate(From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days))
- Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration(From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days))
- Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration(From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days))
- Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration(From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days))
- Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration(From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days))
- Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration(From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days))
- Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)(At visit 4 day 98, ± 7 days)
- Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration(From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days))