Clinical trial NCT05843721: Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
Official title: An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: INCLUSION AND EXCLUSION CRITERIA:

Inclusion Criteria

1. 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;
2. Male or female aged between 18 and 70 years (inclusive) at the time of providing informed consent;
3. 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);
4. Migraine onset before the age of 65 years;
5. Reported history of migraine for at least 1 year before screening;
6. 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;
7. 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

1. Unable to distinguish between migraine headache and other headache types;
2. An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity.
3. Nasal cavity abnormalities that prevents catheter insertion.
4. A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel).
5. A known allergy to polyurethane (polyurethane is used in the catheter balloon).
6. Systemic diseases with manifestations in the nose.
7. Previous treatment with radiation therapy to the nasal area.
8. Nasal surgery performed within the last six months.
9. 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;
10. Pregnant and lactating women;
11. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
12. Previous participation in this study;
13. 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.
timeFrame: Baseline to 12 month
measure: To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.
timeFrame: Baseline to 12 month
measure: Number of patients who are responders
timeFrame: Baseline to 12 month
measure: Number of patients who decrease use of abortive medication
timeFrame: Baseline to 12 month
measure: Mean change in Headache Impact Test (HIT-6)
timeFrame: Baseline to 12 month
measure: Mean change in Subject global severity
timeFrame: Baseline to 12 month
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz
city: Frankfurt am main
country: Germany
facility: Kopfschmerzzentrum Frankfurt
city: Leipzig
country: Germany
facility: Klinikum St. Georg Klinik für Neurologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Klinik für Neurologie
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Neurology Clinics,
city: L'Aquila
country: Italy
facility: Università de L'Aquila Dipartimento di Scienze Cliniche applicate e Biotecnologie SSD Neurologia
city: Milano
country: Italy
facility: IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee
city: Pavia
country: Italy
facility: Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore
city: Bern
country: Switzerland
facility: Universitätsklinik für Neurologie Inselspital
city: Glasgow
country: United Kingdom
facility: Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary, Hull University Teaching Hospital NHS Trust
city: London
country: United Kingdom
facility: National Migraine Centre
city: London
country: United Kingdom
facility: St. George's University Hospitals NHS Foundation Trust
Study officials:
affiliation: Wellcome Foundation Building, Denmark Hill Campus King's College London
name: Peter J Goadsby, Prof,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: