Migraine
Conditions
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.
Interventions
DEVICEChordate System S200 + CT100 (active treatment)
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).
DEVICEChordate System S200 + CT100 (placebo treatment)
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.
Sponsors
Chordate Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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) | — |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chordate System S200 + CT100 (Active Treatment) Chordate System S200 + CT100 (active treatment) is Kinetic Oscillation Stimulation (KOS) treatment with the Chordate System S200 + CT100 | 44 |
| Chordate System S200 + CT100 (Placebo Treatment) Chordate System S200 + CT100 (placebo treatment), is Placebo treatment with the Chordate System S200 + CT100 without an inflated catheter and without vibrations | 43 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Chordate System S200 + CT100 (Placebo Treatment) | Chordate System S200 + CT100 (Active Treatment) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 44 Participants | 87 Participants |
| Age, Continuous | 49.0 years STANDARD_DEVIATION 10.5 | 45.6 years STANDARD_DEVIATION 11.7 | 47.3 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Sweden | 43 participants | 44 participants | 87 participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 61 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 44 | 30 / 43 |
| serious Total, serious adverse events | 1 / 44 | 0 / 43 |
Outcome results
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.
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration | -1.5 Migraine days/four weeks | Standard Deviation 3.6 |
| Chordate System S200 + CT100 (Placebo Treatment) | Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration | -1.3 Migraine days/four weeks | Standard Deviation 3 |
p-value: 0.6938ANCOVA
Secondary
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)
Population: No statistical analysis was done; only tabular listing. All patients that completed treatment were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration | 157 Number of medications |
| Chordate System S200 + CT100 (Placebo Treatment) | Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration | 125 Number of medications |
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.
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | 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 | Month 1 | -1.4 Migraine days/four weeks | Standard Deviation 3.9 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Month 2 | -2.2 Migraine days/four weeks | Standard Deviation 4 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Month 3 | -1.4 Migraine days/four weeks | Standard Deviation 4.1 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Final 4 weeks | -1.1 Migraine days/four weeks | Standard Deviation 4.4 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Final 4 weeks | -1.7 Migraine days/four weeks | Standard Deviation 3.3 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Month 1 | -1.1 Migraine days/four weeks | Standard Deviation 3.9 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Month 3 | -2.2 Migraine days/four weeks | Standard Deviation 3.6 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Month 2 | -0.8 Migraine days/four weeks | Standard Deviation 3.5 |
Comparison: Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation durationp-value: 0.6557ANCOVA
Comparison: 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 durationp-value: 0.515ANCOVA
Comparison: 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 durationp-value: 0.3256ANCOVA
Comparison: 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.p-value: 0.4086ANCOVA
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.
Time frame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration | VAS Pain score at visit 2 | 79.7 score on a scale | Standard Deviation 15 |
| Chordate System S200 + CT100 (Active Treatment) | Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration | VAS pain score at visit 4 | 77.8 score on a scale | Standard Deviation 14.5 |
| Chordate System S200 + CT100 (Placebo Treatment) | Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration | VAS Pain score at visit 2 | 80.6 score on a scale | Standard Deviation 15.1 |
| Chordate System S200 + CT100 (Placebo Treatment) | Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration | VAS pain score at visit 4 | 79.8 score on a scale | Standard Deviation 15 |
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.
Time frame: From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 3 | Moderate | 15 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 1 | Mild | 6 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 3 | Severe | 17 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 2 | Moderate | 14 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Final 4 weeks | Mild | 5 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 1 | Severe | 19 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Final 4 weeks | Moderate | 18 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 2 | Severe | 19 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Final 4 weeks | Severe | 13 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Complete 3 Months | Mild | 1 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 1 | Moderate | 13 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Complete 3 Months | Moderate | 11 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 3 | Mild | 4 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Complete 3 Months | Severe | 27 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 2 | Mild | 5 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Complete 3 Months | Severe | 24 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 1 | Mild | 5 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 1 | Moderate | 14 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 1 | Severe | 17 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 2 | Mild | 2 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 2 | Moderate | 17 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 2 | Severe | 17 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 3 | Mild | 8 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 3 | Moderate | 14 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Month 3 | Severe | 12 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Final 4 weeks | Mild | 5 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Final 4 weeks | Moderate | 14 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Complete 3 Months | Mild | 1 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Complete 3 Months | Moderate | 12 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration | Final 4 weeks | Severe | 15 Participants |
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.
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | 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 | Month 2 | 0.2 Hours / day | Standard Deviation 3.9 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Final 4 weeks | 1.0 Hours / day | Standard Deviation 5.7 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Month 3 | 0.6 Hours / day | Standard Deviation 5.1 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Complete 3 Months | -0.6 Hours / day | Standard Deviation 3.4 |
| Chordate System S200 + CT100 (Active Treatment) | 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 | Month 1 | -0.7 Hours / day | Standard Deviation 3.3 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Complete 3 Months | 0.2 Hours / day | Standard Deviation 3.1 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Month 1 | 0.1 Hours / day | Standard Deviation 2.5 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Month 2 | 1.3 Hours / day | Standard Deviation 5 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Month 3 | -0.4 Hours / day | Standard Deviation 4.9 |
| Chordate System S200 + CT100 (Placebo Treatment) | 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 | Final 4 weeks | 0.0 Hours / day | Standard Deviation 4.1 |
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.
Time frame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Self-care | No change | 39 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Usual activities | Worsened | 2 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Motility | No change | 38 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Pain/Discomfort | Improved | 4 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Self-care | Worsened | 0 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Pain/Discomfort | No change | 25 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Self-care | Improved | 0 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Pain/Discomfort | Worsened | 10 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Usual activities | Improved | 0 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Anxiety/Depression | Improved | 3 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Motility | Worsened | 1 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Anxiety/Depression | No change | 30 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Usual activities | No change | 37 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Anxiety/Depression | Worsened | 6 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Motility | Improved | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Anxiety/Depression | Worsened | 3 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Motility | Improved | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Motility | No change | 38 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Motility | Worsened | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Self-care | Improved | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Self-care | No change | 38 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Self-care | Worsened | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Usual activities | Improved | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Usual activities | No change | 37 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Usual activities | Worsened | 1 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Pain/Discomfort | Improved | 6 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Pain/Discomfort | No change | 22 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Pain/Discomfort | Worsened | 10 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Anxiety/Depression | Improved | 4 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration | Anxiety/Depression | No change | 31 Participants |
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).
Time frame: At visit 4 day 98, ± 7 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Much improved | 10 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Very much improved | 3 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Minimally worse | 2 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Minimally improved | 14 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Much worse | 1 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | No change | 10 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Much worse | 0 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Very much improved | 1 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Much improved | 5 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Minimally improved | 12 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | No change | 18 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI) | Minimally worse | 2 Participants |
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
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chordate System S200 + CT100 (Active Treatment) | Responder Rate | Month 1 | 14 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Responder Rate | Month 2 | 15 Participants |
| Chordate System S200 + CT100 (Active Treatment) | Responder Rate | Month 3 | 12 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Responder Rate | Month 1 | 7 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Responder Rate | Month 2 | 10 Participants |
| Chordate System S200 + CT100 (Placebo Treatment) | Responder Rate | Month 3 | 15 Participants |