NCT05843721

Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine

An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Chordate Medical · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DEVICE	KOS (Intranasal kinetic oscillation stimulation)	Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.

Timeline

• Start date: 2023-11-08
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2023-05-06
• Last updated: 2025-09-12

Locations

12 sites across 4 countries: Germany, Israel, Italy, United Kingdom