Clinical trial NCT05273151: A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 30
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
Intervention model description: Open label Investigation
Primary purpose: PREVENTION

Brief summary: An open pilot study, non-controlled, single center investigation.

Detailed description: 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.

Eligibility 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 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);
4. Migraine onset before the age of 50 years.
5. Reported history of migraine for at least 1 year before screening.
6. If subjects are on a preventive treatment at the time of screening, this must have been stable over the preceding 3 months.
7. 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-
8. Failed at least 3 different preventive medications and 3 months of treatment with a CGRP targeting therapy.
9. 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 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;

Primary outcomes:
measure: Mean change in headache days
timeFrame: baseline to 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline to 12 weeks
measure: Incidence of adverse events (AEs) and adverse device effects (ADEs)
timeFrame: Baseline to 12 weeks
measure: Number of patients who are responders
timeFrame: baseline to 12 weeks
measure: Number of patients who decrease use of abortive medication
timeFrame: baseline to 12 weeks
measure: Mean change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline to 12 weeks
measure: Mean change in Headache Impact Test (HIT-6)
timeFrame: baseline to 12 weeks
measure: Mean change in Subject global severity
timeFrame: baseline to 12 weeks
measure: Mean change in headache days
timeFrame: week 6-12
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Kopfschmerzzentrum Frankfurt
city: Bern
country: Switzerland
facility: Universitätsklinik für Neurologie Inselspital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary, Hull University Teaching Hospital
city: London
country: United Kingdom
facility: Wolfson Centre for Age-Related Diseases Institute of Psychiatry, Psychology and Neuroscience Wellcome Foundation Building, Denmark Hill Campus King's College
Study officials:
affiliation: Wellcome Foundation Building, Denmark Hill Campus King's College London
name: Peter J Goadsby, Prof,MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: