Chronic Migraine
Conditions
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.
Interventions
Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.
Sponsors
Chordate Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To 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 days |
| 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 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. |
| 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. Severe |
| Number 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 |
Countries
Germany, Israel, Italy, United Kingdom
Outcome results
None listed