Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-04-16 @ 5:14 PM
Study NCT ID:
NCT05273151
Status:
TERMINATED
Last Update Posted:
2025-07-31
First Post:
2022-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine
Sponsor:
Chordate Medical
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow inclusion due to new treatment (Gepants)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: