Chordate System Prophylactic Migraine Clinical Investigation

Not Applicable

Completed

Conditions: Migraine

Interventions: Device: Chordate System S200 + CT100 (active treatment)
Device: Chordate System S200 + CT100 (placebo treatment)

Registration Number: NCT02243865

Lead Sponsor: Chordate Medical

Brief Summary: The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine.

Detailed Description: This was a prospective, interventional, randomized, placebo-controlled, double-blind, multi-center clinical investigation of a medical device system.

A pilot study in which patients with frequent migraine attacks received intranasal KOS or placebo using the Chordate System S200 on two occasions.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 87

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
Diagnosed as suffering from migraine with or without aura according to International Headache Society´s (IHS) classification (International Classification of Headache Disorders (ICHD), 3rd edition, beta version)
Reported history of 3 to 8 migraine episodes per month during previous 2 months, confirmed during baseline
Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during baseline
Onset of migraine headache occurred before age 50
Reported history of migraine for more than one year
Reported stable dose of prophylactic migraine medication(s), if any, during the two months prior to screening (visit 1), and willing and able to maintain stable dose(s) until the three months follow-up (visit 4)

Exclusion Criteria

Meeting the ICHD criteria for medication overuse
Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during baseline
Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during baseline
Unable to distinguish between migraine headaches and other headache types
Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visits
Ongoing treatment with implanted stimulator or other implanted device in the head and/or neck region
Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds
History of sinus surgery, transphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea
Fitted with a pacemaker/defibrillator
Previously treated with therapeutic radiation to the face (that could have influenced the nasal mucosa)
Ongoing upper respiratory tract infection or a body temperature >38.5°C (at treatment), or malignancy in the nasal cavity
History of regular nose bleeding (epistaxis), or concomitant condition that could cause excessive bleeding, including treatment with the anticoagulant Varan
Head injury or open wound that contraindicates use of Chordate Headband
Known allergy to polyvinylchloride, a material used in the 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
Any change in migraine prophylaxis the previous two months
Pregnant women
Participation in a clinical research study within three months of enrolment or planned participation at any time during this clinical investigation
Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members or any such individuals
Headache or migraine episode within the 48 hours prior to the first treatment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chordate S200 + control module (CT100), active	Chordate System S200 + CT100 (active treatment)	Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril
Chordate S200 + control module (CT100), placebo	Chordate System S200 + CT100 (placebo treatment)	Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration	From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)	A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.

Secondary Outcome Measures

Name	Time	Method
Responder Rate	From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)	"Responder" defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration	From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)	A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration	From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)	A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe). The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration	From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)	Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.
Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration	From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration	From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)	A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1). The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented. As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)	At visit 4 day 98, ± 7 days	Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration	From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)	Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.

Trial Locations

Locations (4): Neurolgy Clinic
🇸🇪
Stockholm, Sweden
Stortorgets neurologmottagning
🇸🇪
Helsingborg, Sweden
Läkarcentrum Stångåblick
🇸🇪
Linköping, Sweden
Neurologmottagningen Vällingby sjukhus
🇸🇪
Vällingby, Sweden