Back to resultsChordate System Prophylactic Migraine Clinical Investigation
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Chordate System S200 + CT100 (active treatment)
Chordate System S200 + CT100 (placebo treatment)
Sponsored by
About this trial
This is an interventional prevention trial for Migraine
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
- 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
Sites / Locations
- Stortorgets neurologmottagning
- Läkarcentrum Stångåblick
- Neurolgy Clinic
- Neurologmottagningen Vällingby sjukhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Chordate S200 + control module (CT100), active
Chordate S200 + control module (CT100), placebo
Arm Description
Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril
Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment
Outcomes
Primary Outcome Measures
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
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
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
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.
Responder Rate
"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
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
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.
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
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.
Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
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).
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
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.
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02243865
Brief Title
Chordate System Prophylactic Migraine Clinical Investigation
Official Title
A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chordate Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
A placebo module, with one input and 6 outputs, was added to the Chordate S200 system. Some outputs delivered active treatment and others placebo. The operator received a coded envelope and according to that, either active treatment or placebo was selected. The operator did not know which outputs delivered treatment and which did not.
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chordate S200 + control module (CT100), active
Arm Type
Experimental
Arm Description
Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril
Arm Title
Chordate S200 + control module (CT100), placebo
Arm Type
Placebo Comparator
Arm Description
Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment
Intervention Type
Device
Intervention Name(s)
Chordate System S200 + CT100 (active treatment)
Intervention Description
Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).
Intervention Type
Device
Intervention Name(s)
Chordate System S200 + CT100 (placebo treatment)
Intervention Description
Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.
Primary Outcome Measure Information:
Title
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
Description
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.
Time Frame
From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Title
Responder Rate
Description
"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
Time Frame
From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Title
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Description
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.
Time Frame
From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)
Title
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
Description
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.
Time Frame
From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Title
Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
Time Frame
From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Title
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Description
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).
Time Frame
At visit 4 day 98, ± 7 days
Title
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Description
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.
Time Frame
From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Title
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
Description
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.
Time Frame
From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan-Åke Åkesson, MD
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
Facility Information:
Facility Name
Stortorgets neurologmottagning
City
Helsingborg
ZIP/Postal Code
25220
Country
Sweden
Facility Name
Läkarcentrum Stångåblick
City
Linköping
ZIP/Postal Code
582 19
Country
Sweden
Facility Name
Neurolgy Clinic
City
Stockholm
ZIP/Postal Code
11433
Country
Sweden
Facility Name
Neurologmottagningen Vällingby sjukhus
City
Vällingby
ZIP/Postal Code
162 68
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chordate System Prophylactic Migraine Clinical Investigation
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