A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine

Study Overview
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Brief Summary
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An open pilot study, non-controlled, single center investigation.

Detailed Description
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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.

Official Title
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A Pilot Study to Evaluate the Efficacy of Intranasal K.O.S in the Preventive Treatment of Chronic Migraine on Patients Not Responding to a Treatment With Monoclonal Antibodies Targeting the CGRP Pathway.

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: KOS (Intranasal kinetic oscillation stimulation)


Participation Criteria
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Eligibility Criteria
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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 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 monoclonal antibody targeting the CGRP pathway. 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 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open label Investigation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: KOS treatment<br>Treatment with intranasal kinetic oscillation stimulation (KOS) | Device: KOS (Intranasal kinetic oscillation stimulation)<br>* Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in headache days | Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary | baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Migraine days is collected in an eDiary. | Baseline to 12 weeks | 
| Incidence of adverse events (AEs) and adverse device effects (ADEs) | All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with the Chordate System 220 | Baseline to 12 weeks | 
| Number of patients who are responders | Responders are classified as responder (less migraine/headache days) or non-responder (same or worsening of migraine/headache days). A respondes is a patient who has decrease of headaches/migraine days whilst a non responder had no or the same number of headache/migraine days | baseline to 12 weeks | 
| Number of patients who decrease use of abortive medication | Intake of abortive medications are registred in eDiary and will be calculated on patient level | baseline to 12 weeks | 
| Mean change in Hospital Anxiety and Depression Scale (HADS) | HADS is a scale with 7 questions related to anxiety and 7 questions related to depression Anxiety can have 0-21 points (lower score means no anxiety) and Depression 0-21 points (higher score means no depression) | baseline to 12 weeks | 
| Mean change in Headache Impact Test (HIT-6) | HIT-6 consist of 6 questions HIT-6 with scores from 6 to 13 where 13 is worst case per question so lower score means less problems | baseline to 12 weeks | 
| Mean change in Subject global severity | Patient Global severity is a scale with four (4) scores, where normal (0) is the lowest and show no problems whilst severe (3) is the worst score 0=Normal Mild Moderate Severe | baseline to 12 weeks | 
| Mean change in headache days | Change in headache days with moderate to severe intensity from eDiary | week 6-12 |