Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

Chordate Medical144 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

144

Conditions

Chronic Migraine

Interventions

Chordate System S211 in treatment modeDEVICE

Chordate System S211 in treatment mode

Chordate System S211 in placebo modeDEVICE

Chordate System S211 in placebo mode

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (10)

Terveystalo Ruoholahti

Helsinki, Finland

Helsingin päänsärkykeskus / Aava Itäkeskus

Helsinki, Finland

Terveystalo Tampere

Tampere, Finland

Outcomes

Primary Outcomes

Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.

Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.

Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Secondary Outcomes

Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days

Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Mean Change From Baseline to Follow-up Period in Monthly Migraine Days

Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities

Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities

Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Data from ClinicalTrials.gov

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Suomen Terveystalo Turku

Lewis Neurologie

Stuttgart, Baden-Wurttemberg, Germany

Neurologie- & Kopfschmerzzentrum

München, Bavaria, Germany

Klinikum Großhadern / Neurologische Klinik der Universität München

München, Bavaria, Germany

Migräne-Klinik Königstein

Königstein im Taunus, Hesse, Germany

Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie

Rostock, Mecklenburg-Vorpommern, Germany

CTC North am Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Change in the Use of Abortive Medication in Performance Assessment Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Change in the Use of Abortive Medication in Follow-up Period

Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Headache Impact Test

The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact. Reported is the change from Baseline in the final total score at the respective visit.

Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive

The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit.

Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

MSQ - Role Function - Preventive

The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit.

Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

MSQ - Emotional Function

The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit.

Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

Patient Global Impression of Severity (PGI-S)

The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe

Time frame: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)

Incidence of Adverse Events (AEs)

n (%) of patients

Time frame: Days 0, 7, 14, 21, 28, 35, 42, 70