Clinical trial NCT03400059: Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Keywords: Prophylaxis, Headache, Preventative Treatment
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
Collaborators: name: Vinnova
name: FGK Clinical Research GmbH
First posted: 2018-01-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of a medical device. The study consists of a 4-week screening period, a 6-week treatment period (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week follow-up period.

The study primarily aims at evaluating the effect of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment on monthly headache days with moderate to severe intensity.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;
3. 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);
4. Migraine onset before the age of 60 years;
5. Reported history of migraine for at least 1 year before screening;
6. Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
7. Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;
8. 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:

1. Unable to distinguish between migraine headaches and other headache types;
2. Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
3. Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
4. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
5. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;
6. Fitted with a pacemaker/defibrillator;
7. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
8. Ongoing upper respiratory infection or malignancy in the nasal cavity;
9. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
10. Head injury or open wound that contraindicates use of the Chordate Headband;
11. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;
12. 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;
13. Pregnant and lactating women;
14. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
15. Previous participation in this study;
16. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.

Primary outcomes:
measure: Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Secondary outcomes:
measure: Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
measure: Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
measure: Mean Change From Baseline to Follow-up Period in Monthly Migraine Days
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
measure: Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
measure: Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
measure: Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
measure: Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
measure: Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
measure: Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
measure: Change in the Use of Abortive Medication in Performance Assessment Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
measure: Change in the Use of Abortive Medication in Follow-up Period
timeFrame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
measure: Headache Impact Test
timeFrame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
measure: Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive
timeFrame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
measure: MSQ - Role Function - Preventive
timeFrame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
measure: MSQ - Emotional Function
timeFrame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)
measure: Incidence of Adverse Events (AEs)
timeFrame: Days 0, 7, 14, 21, 28, 35, 42, 70
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
city: Helsinki
country: Finland
facility: Helsingin päänsärkykeskus / Aava Itäkeskus
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Turku
country: Finland
facility: Suomen Terveystalo Turku
city: Stuttgart
country: Germany
facility: Lewis Neurologie
state: Baden-Württemberg
city: München
country: Germany
facility: Neurologie- & Kopfschmerzzentrum
state: Bayern
city: München
country: Germany
facility: Klinikum Großhadern / Neurologische Klinik der Universität München
state: Bayern
city: Königstein Im Taunus
country: Germany
facility: Migräne-Klinik Königstein
state: Hessen
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie
state: Mecklenburg-Vorpommern
city: Hamburg
country: Germany
facility: CTC North am Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Arne May, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: