Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
- Conditions
- Chronic Migraine
- Interventions
- Device: KOS (Intranasal kinetic oscillation stimulation)
- Registration Number
- NCT05843721
- Lead Sponsor
- Chordate Medical
- Brief Summary
An non controlled, long term, multi center investigation
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KOS treatment KOS (Intranasal kinetic oscillation stimulation) Treatment with intranasal kinetic oscillation stimulation (KOS)
- Primary Outcome Measures
Name Time Method 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. 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)
- Secondary Outcome Measures
Name Time Method 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 Migraine days is collected in an eDiary.
Mean change in Subject global severity Baseline to 12 month 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
1. Mild
2. Moderate
3. SevereTo 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 All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with KOS
Number of patients who are responders Baseline to 12 month Responders are classified as responder (less migraine/headache days) or non-responder (same or worsening of migraine/headache days).
A responder is a patient who has decrease of headache/migraine days whilst a non responder had no or the same number of headache/migraine daysNumber of patients who decrease use of abortive medication Baseline to 12 month Intake of abortive medications are registered in eDiary and will be calculated on patient level
Mean change in Headache Impact Test (HIT-6) Baseline to 12 month HIT-6 consist of 6 questions HIT-6 with scores from 6 to 13 where 13 is worst case per question so lower score is better outcome than high scores.
Trial Locations
- Locations (16)
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum
🇩🇪Dresden, Germany
Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz
🇩🇪Essen, Germany
Kopfschmerzzentrum Frankfurt
🇩🇪Frankfurt am main, Germany
Klinikum St. Georg Klinik für Neurologie
🇩🇪Leipzig, Germany
Universitätsklinikum Tübingen Klinik für Neurologie
🇩🇪Tübingen, Germany
Shaare Zedek Medical Center, Neurology Clinics,
🇮🇱Jerusalem, Israel
Università de L'Aquila Dipartimento di Scienze Cliniche applicate e Biotecnologie SSD Neurologia
🇮🇹L'Aquila, Italy
IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee
🇮🇹Milano, Italy
Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation
🇮🇹Pavia, Italy
Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia
🇮🇹Roma, Italy
IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore
🇮🇹Roma, Italy
Universitätsklinik für Neurologie Inselspital
🇨🇭Bern, Switzerland
Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Hull Royal Infirmary, Hull University Teaching Hospital NHS Trust
🇬🇧Hull, United Kingdom
National Migraine Centre
🇬🇧London, United Kingdom
St. George's University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom