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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chordate S200 + control module (CT100), active | Experimental | Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril |
|
| Chordate S200 + control module (CT100), placebo | Placebo Comparator | Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chordate System S200 + CT100 (active treatment) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan-Åke Åkesson, MD | Linkoeping University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stortorgets neurologmottagning | Helsingborg | 25220 | Sweden | |||
| Läkarcentrum Stångåblick |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chordate System S200 + CT100 (Active) Treatment | Chordate System S200 + control module (CT100), active treatment: 44 subjects |
| FG001 | Chordate System S200 + CT100 (Placebo Treatment) | Chordate System S200 + control module (CT100), placebo treatment: 38 subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chordate System S200 + CT100 (Active Treatment) | Chordate System S200 + CT100 (active treatment) is Kinetic Oscillation Stimulation (KOS) treatment with the Chordate System S200 + CT100 |
| BG001 | Chordate System S200 + CT100 (Placebo Treatment) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment. Only patients who completed treatment were included in analysis (see participant flow). | Posted | Mean | Standard Deviation | Migraine days/four weeks | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chordate System S200 + CT100 (Active Treatment) | Chordate System S200 + CT100 (active treatment): 44 subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laminar hole of the macula | Eye disorders | MedDRA (8.0) | Non-systematic Assessment | Pat P7-05 presented with laminar hole of the macula of the right Eye 5 weeks after treatment.The event was assessed as not related to the device and related to the procedure. Conc. diseases were hypertension, dyspepsia and optic neuritis left Eye. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased nasal secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jan-Åke Åkesson | Chordate | +46 8 40015586 | info@chordate.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
| Chordate System S200 + CT100 (placebo treatment) | Device | 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. |
|
| From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 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 | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 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 | 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. | From baseline (day ≥ - 28 days) 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 | 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. | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
| 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) |
| 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). | At visit 4 day 98, ± 7 days |
| 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. | From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days) |
| 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. | From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days) |
| Linköping |
| 582 19 |
| Sweden |
| Neurolgy Clinic | Stockholm | 11433 | Sweden |
| Neurologmottagningen Vällingby sjukhus | Vällingby | 162 68 | Sweden |
| Withdrawal by Subject |
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| Adverse Event |
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Chordate System S200 + CT100 (placebo treatment), is Placebo treatment with the Chordate System S200 + CT100 without an inflated catheter and without vibrations |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint. | Posted | Mean | Standard Deviation | Migraine days/four weeks | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
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| Secondary | 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 | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint. | Posted | Count of Participants | Participants | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
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| Secondary | 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. | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint. | Posted | Count of Participants | Participants | From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days) |
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| Secondary | 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. | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint. | Posted | Mean | Standard Deviation | Hours / day | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
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| Secondary | Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration | No statistical analysis was done; only tabular listing. All patients that completed treatment were included. | Posted | Number | Number of medications | From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days) |
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| Secondary | 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). | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. | Posted | Count of Participants | Participants | At visit 4 day 98, ± 7 days |
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| Secondary | 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. | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint. | Posted | Count of Participants | Participants | From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days) |
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| Secondary | 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. | 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days) |
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| 1 |
| 44 |
| 44 |
| 44 |
| EG001 | Chordate System S200 + CT100 (Placebo Treatment) | Chordate System S200 + CT100 (placebo treatment): 43 subjects | 0 | 43 | 30 | 43 |
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| Increased tear secretion | Eye disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Mild burning sensation | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Paraesthesia of the lip | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Slight discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Slight pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| D009422 | Nervous System Diseases |
| Month 3 |
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| Final 4 weeks |
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Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration |
| ANCOVA |
In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start. |
| 0.515 |
| Superiority |
| Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration | ANCOVA | In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start. | 0.3256 | Superiority |
| Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration. | ANCOVA | In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start. | 0.4086 | Superiority |
| Month 3 |
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| Moderate |
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| Severe |
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| Month 2 |
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| Month 3 |
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| Final 4 weeks |
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| Complete 3 Months |
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| Month 2 |
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| Month 3 |
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| Final 4 weeks |
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| Complete 3 Months |
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| Minimally improved |
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| No change |
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| Minimally worse |
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| Much worse |
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| Worsened |
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| Self-care |
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| Usual activities |
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| Pain/Discomfort |
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| Anxiety/Depression |
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