NCT03400059CompletedNot Applicable
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Chordate Medical10 sites in 2 countries144 target enrollmentStarted: March 22, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Locations
- 10
- Primary Endpoint
- Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sham Treatment
Sham Comparator
Intervention: Chordate System S211 in placebo mode (Device)
Active Treatment
Experimental
Intervention: Chordate System S211 in treatment mode (Device)
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.
Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
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.
Secondary Outcomes
- Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities(Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42)
- Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period(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(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(Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70)
- Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities(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(Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42)
- Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period(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(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(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(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(Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70)
- Headache Impact Test(Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up))
- Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive(Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up))
- MSQ - Role Function - Preventive(Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up))
- MSQ - Emotional Function(Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up))
- Patient Global Impression of Severity (PGI-S)(Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up))
- Incidence of Adverse Events (AEs)(Days 0, 7, 14, 21, 28, 35, 42, 70)
Investigators
Study Sites (10)
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