An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Migraine
- Sponsor
- Chordate Medical
- Enrollment
- 98
- Locations
- 12
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- 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)
- Mean change in Subject global severity(Baseline to 12 month)
- 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)
- Number of patients who are responders(Baseline to 12 month)
- Number of patients who decrease use of abortive medication(Baseline to 12 month)
- Mean change in Headache Impact Test (HIT-6)(Baseline to 12 month)