N/A
Completed N=144
Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Source: ClinicalTrials.gov NCT03400059 ↗Enrolled (actual)
144
Serious AEs
0.7%
Results posted
Jan 2025
Primary outcomePrimary: Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period. — -3.45; -1.22 change in days — p=0.0132
Summary
The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment will be examined in patients diagnosed with chronic migraine. The medical device system will be applied in 6 treatments at weekly intervals. The study will examine the effects on monthly headache days with moderate to severe intensity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period. |
-3.45; -1.22 | 0.0132 sig |
| SECONDARY Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period |
-3.15; -0.47 | 0.0014 sig |
| SECONDARY Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days |
-3.57; -1.17 | 0.0048 sig |
| SECONDARY Mean Change From Baseline to Follow-up Period in Monthly Migraine Days |
-3.72; -0.85 | 0.0008 sig |
| SECONDARY Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities |
-2.88; -1.35 | 0.0598 |
| SECONDARY Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities |
-3.65; -1.75 | 0.0310 sig |
| SECONDARY Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period |
32; 17 | 0.0102 sig |
| SECONDARY Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period |
27; 19 | 0.1615 |
| SECONDARY Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period |
20; 11 | 0.0798 |
| SECONDARY Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period |
16; 9 | 0.1300 |
| SECONDARY Change in the Use of Abortive Medication in Performance Assessment Period |
-2.016; -0.857 | 0.0660 |
| SECONDARY Change in the Use of Abortive Medication in Follow-up Period |
-2.490; -0.660 | 0.0152 sig |
| SECONDARY Headache Impact Test |
-2.6; -1.5; -4.1; -2.2; -3.8; -1.7 | — |
| SECONDARY Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive |
7.4; 5.4; 13.3; 7.5; 11.9; 4.9 | — |
| SECONDARY MSQ - Role Function - Preventive |
4.2; 0.7; 9.2; 4.8; 9.8; -0.7 | — |
| SECONDARY MSQ - Emotional Function |
7.0; 3.0; 10.2; 5.8; 11.5; 2.5 | — |
| SECONDARY Patient Global Impression of Severity (PGI-S) |
1; 0; 13; 13; 7; 4 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
49; 41; 48; 41; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 (ICF);
- Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;
- Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month for more than 3 months before screening including at least 8 migraine days) according to the IHS classification (International Classification of Headache Disorders [ICHD]-III beta);
- Migraine onset before the age of 60 years;
- Reported history of migraine for at least 1 year before screening;
- Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
- Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;
- 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.
Exclusion Criteria
- Unable to distinguish between migraine headaches and other headache types;
- Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
- Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
- Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
- History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;
- Fitted with a pacemaker/defibrillator;
- Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
- Ongoing upper respiratory infection or malignancy in the nasal cavity;
- History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
- Head injury or open wound that contraindicates use of the Chordate Headband;
- Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;
- Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;
- Pregnant and lactating women;
- Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
- Previous participation in this study;
- Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.
Data sourced from ClinicalTrials.gov (NCT03400059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.