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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Migraine
- Sponsor
- Chordate Medical
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Mean change in headache days
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean change in headache days
Time Frame: baseline to 6 weeks
Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary
Secondary Outcomes
- Mean change in Hospital Anxiety and Depression Scale (HADS)(baseline to 12 weeks)
- Number of patients who decrease use of abortive medication(baseline to 12 weeks)
- Mean change in headache days(week 6-12)
- Incidence of adverse events (AEs) and adverse device effects (ADEs)(Baseline to 12 weeks)
- 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)(Baseline to 12 weeks)
- Number of patients who are responders(baseline to 12 weeks)
- Mean change in Headache Impact Test (HIT-6)(baseline to 12 weeks)
- Mean change in Subject global severity(baseline to 12 weeks)