Chronic Migraine
Conditions
Keywords
Prophylaxis, Headache, Preventative Treatment
Brief summary
The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment will be examined in patients diagnosed with chronic migraine. The medical device system will be applied in 6 treatments at weekly intervals. The study will examine the effects on monthly headache days with moderate to severe intensity.
Detailed description
This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of a medical device. The study consists of a 4-week screening period, a 6-week treatment period (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week follow-up period. The study primarily aims at evaluating the effect of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment on monthly headache days with moderate to severe intensity.
Interventions
DEVICEChordate System S211 in treatment mode
Chordate System S211 in treatment mode
DEVICEChordate System S211 in placebo mode
Chordate System S211 in placebo mode
Sponsors
Vinnova
FGK Clinical Research GmbH
Chordate Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 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); 2. Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent; 3. Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month for more than 3 months before screening including at least 8 migraine days) according to the IHS classification (International Classification of Headache Disorders \[ICHD\]-III beta); 4. Migraine onset before the age of 60 years; 5. Reported history of migraine for at least 1 year before screening; 6. Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening; 7. Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up; 8. Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate \<1% per year when used consistently and correctly) during the study.
Exclusion criteria
1. Unable to distinguish between migraine headaches and other headache types; 2. Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study; 3. Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck; 4. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds; 5. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea; 6. Fitted with a pacemaker/defibrillator; 7. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa); 8. Ongoing upper respiratory infection or malignancy in the nasal cavity; 9. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant; 10. Head injury or open wound that contraindicates use of the Chordate Headband; 11. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin; 12. 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; 13. Pregnant and lactating women; 14. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation; 15. Previous participation in this study; 16. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period. | Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 | Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days | Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 | — |
| Mean Change From Baseline to Follow-up Period in Monthly Migraine Days | Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70 | — |
| Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 | — |
| Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70 | — |
| Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period | Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 | — |
| Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period | Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70 | — |
| Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period | Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 | — |
| Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period | Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70 | — |
| Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period | Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70 | — |
| Change in the Use of Abortive Medication in Follow-up Period | Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70 | — |
| Headache Impact Test | Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up) | The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact. Reported is the change from Baseline in the final total score at the respective visit. |
| Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up) | The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit. |
| MSQ - Role Function - Preventive | Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up) | The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit. |
| MSQ - Emotional Function | Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up) | The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit. |
| Patient Global Impression of Severity (PGI-S) | Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up) | The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe |
| Incidence of Adverse Events (AEs) | Days 0, 7, 14, 21, 28, 35, 42, 70 | n (%) of patients |
| Change in the Use of Abortive Medication in Performance Assessment Period | Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 | — |
Countries
Finland, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Chordate System S211 in treatment mode: Chordate System S211 in treatment mode | 76 |
| Sham Treatment Chordate System S211 in placebo mode: Chordate System S211 in placebo mode | 68 |
| Total | 144 |
Baseline characteristics
| Characteristic | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 67 Participants | 143 Participants |
| Age, Continuous | 48 years | 46 years | 48 years |
| BMI | 26.3 kg/m^2 STANDARD_DEVIATION 5.6 | 25.3 kg/m^2 STANDARD_DEVIATION 5 | 25.9 kg/m^2 STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized Arabian (Jordan) | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 75 Participants | 68 Participants | 143 Participants |
| Region of Enrollment Finland | 25 participants | 22 participants | 47 participants |
| Region of Enrollment Germany | 51 participants | 46 participants | 97 participants |
| Sex: Female, Male Female | 65 Participants | 57 Participants | 122 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 68 |
| other Total, other adverse events | 49 / 76 | 41 / 68 |
| serious Total, serious adverse events | 1 / 76 | 0 / 68 |
Outcome results
Primary
Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.
Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period. | -3.45 change in days | Standard Error 0.62 |
| Sham Treatment | Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period. | -1.22 change in days | Standard Error 0.62 |
p-value: 0.013295% CI: [-4.11, -0.49]ANCOVA
Secondary
Change in the Use of Abortive Medication in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Change in the Use of Abortive Medication in Follow-up Period | -2.490 change in days | Standard Deviation 4.26 |
| Sham Treatment | Change in the Use of Abortive Medication in Follow-up Period | -0.660 change in days | Standard Deviation 5.552 |
p-value: 0.0152Van-Elteren
Secondary
Change in the Use of Abortive Medication in Performance Assessment Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Change in the Use of Abortive Medication in Performance Assessment Period | -2.016 change in days | Standard Deviation 4.565 |
| Sham Treatment | Change in the Use of Abortive Medication in Performance Assessment Period | -0.857 change in days | Standard Deviation 4.721 |
p-value: 0.066Van-Elteren
Secondary
Headache Impact Test
The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact. Reported is the change from Baseline in the final total score at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Population: assessments of individual subjects missing at some visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment | Headache Impact Test | Visit 3 | -2.6 change in score on a scale from Baseline | Standard Deviation 5.2 |
| Active Treatment | Headache Impact Test | Visit 7 | -4.1 change in score on a scale from Baseline | Standard Deviation 6.8 |
| Active Treatment | Headache Impact Test | Follow-up visit | -3.8 change in score on a scale from Baseline | Standard Deviation 7.4 |
| Sham Treatment | Headache Impact Test | Visit 3 | -1.5 change in score on a scale from Baseline | Standard Deviation 3.1 |
| Sham Treatment | Headache Impact Test | Visit 7 | -2.2 change in score on a scale from Baseline | Standard Deviation 4.8 |
| Sham Treatment | Headache Impact Test | Follow-up visit | -1.7 change in score on a scale from Baseline | Standard Deviation 5.4 |
Secondary
Incidence of Adverse Events (AEs)
n (%) of patients
Time frame: Days 0, 7, 14, 21, 28, 35, 42, 70
Population: SAF
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Treatment | Incidence of Adverse Events (AEs) | Any treatment emergent adverse event | 48 Participants |
| Active Treatment | Incidence of Adverse Events (AEs) | Any treatment emergent adverse event related to medical device | 2 Participants |
| Active Treatment | Incidence of Adverse Events (AEs) | any serious treatment emergent adverse event | 1 Participants |
| Active Treatment | Incidence of Adverse Events (AEs) | Any treatment emergent adverse event related to procedure | 17 Participants |
| Active Treatment | Incidence of Adverse Events (AEs) | Any adverse event | 49 Participants |
| Sham Treatment | Incidence of Adverse Events (AEs) | Any treatment emergent adverse event related to procedure | 13 Participants |
| Sham Treatment | Incidence of Adverse Events (AEs) | Any adverse event | 41 Participants |
| Sham Treatment | Incidence of Adverse Events (AEs) | Any treatment emergent adverse event | 41 Participants |
| Sham Treatment | Incidence of Adverse Events (AEs) | any serious treatment emergent adverse event | 0 Participants |
| Sham Treatment | Incidence of Adverse Events (AEs) | Any treatment emergent adverse event related to medical device | 5 Participants |
Secondary
Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period | -3.15 change in days | Standard Error 0.59 |
| Sham Treatment | Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period | -0.47 change in days | Standard Error 0.59 |
p-value: 0.001495% CI: [-4.32, -1.04]ANCOVA
Secondary
Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | -3.65 change in days | Standard Error 0.62 |
| Sham Treatment | Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | -1.75 change in days | Standard Error 0.62 |
p-value: 0.03195% CI: [-3.63, -0.17]ANCOVA
Secondary
Mean Change From Baseline to Follow-up Period in Monthly Migraine Days
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Mean Change From Baseline to Follow-up Period in Monthly Migraine Days | -3.72 change in days | Standard Error 0.6 |
| Sham Treatment | Mean Change From Baseline to Follow-up Period in Monthly Migraine Days | -0.85 change in days | Standard Error 0.6 |
p-value: 0.000895% CI: [-4.54, -1.2]ANCOVA
Secondary
Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | -2.88 change in days | Standard Error 0.57 |
| Sham Treatment | Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | -1.35 change in days | Standard Error 0.58 |
p-value: 0.059895% CI: [-3.12, 0.06]ANCOVA
Secondary
Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days | -3.57 change in days | Standard Error 0.6 |
| Sham Treatment | Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days | -1.17 change in days | Standard Error 0.6 |
p-value: 0.004895% CI: [-4.06, -0.73]ANCOVA
Secondary
Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive
The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Population: assessments of individual subjects missing at some visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment | Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Visit 3 | 7.4 change in score on a scale from Baseline | Standard Deviation 16.3 |
| Active Treatment | Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Visit 7 | 13.3 change in score on a scale from Baseline | Standard Deviation 19.9 |
| Active Treatment | Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Follow-up | 11.9 change in score on a scale from Baseline | Standard Deviation 21.4 |
| Sham Treatment | Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Visit 3 | 5.4 change in score on a scale from Baseline | Standard Deviation 11.2 |
| Sham Treatment | Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Visit 7 | 7.5 change in score on a scale from Baseline | Standard Deviation 17 |
| Sham Treatment | Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive | Follow-up | 4.9 change in score on a scale from Baseline | Standard Deviation 19.8 |
Secondary
MSQ - Emotional Function
The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Population: assessments of individual subjects missing at some visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment | MSQ - Emotional Function | Visit 3 | 7.0 change in score on a scale from Baseline | Standard Deviation 16.2 |
| Active Treatment | MSQ - Emotional Function | Visit 7 | 10.2 change in score on a scale from Baseline | Standard Deviation 23.5 |
| Active Treatment | MSQ - Emotional Function | Follow-up | 11.5 change in score on a scale from Baseline | Standard Deviation 25.2 |
| Sham Treatment | MSQ - Emotional Function | Visit 3 | 3.0 change in score on a scale from Baseline | Standard Deviation 14.2 |
| Sham Treatment | MSQ - Emotional Function | Visit 7 | 5.8 change in score on a scale from Baseline | Standard Deviation 19.2 |
| Sham Treatment | MSQ - Emotional Function | Follow-up | 2.5 change in score on a scale from Baseline | Standard Deviation 24.7 |
Secondary
MSQ - Role Function - Preventive
The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Population: assessments of individual subjects missing at some visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment | MSQ - Role Function - Preventive | Visit 3 | 4.2 change in score on a scale from Baseline | Standard Deviation 17.4 |
| Active Treatment | MSQ - Role Function - Preventive | Visit 7 | 9.2 change in score on a scale from Baseline | Standard Deviation 20.8 |
| Active Treatment | MSQ - Role Function - Preventive | Follow-up | 9.8 change in score on a scale from Baseline | Standard Deviation 22.2 |
| Sham Treatment | MSQ - Role Function - Preventive | Visit 3 | 0.7 change in score on a scale from Baseline | Standard Deviation 10.9 |
| Sham Treatment | MSQ - Role Function - Preventive | Visit 7 | 4.8 change in score on a scale from Baseline | Standard Deviation 16.6 |
| Sham Treatment | MSQ - Role Function - Preventive | Follow-up | -0.7 change in score on a scale from Baseline | Standard Deviation 19.8 |
Secondary
Patient Global Impression of Severity (PGI-S)
The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe
Time frame: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)
Population: assessments of individual subjects missing at some visits
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | Not done | 2 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | mild | 13 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Screening | mild | 7 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | severe | 12 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | normal | 21 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | Not done | 1 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | moderate | 21 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | normal | 23 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | mild | 5 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | mild | 17 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Screening | moderate | 25 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | moderate | 21 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | moderate | 22 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | severe | 6 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Screening | normal | 13 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | Not done | 0 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | severe | 21 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | normal | 22 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Screening | severe | 25 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | mild | 17 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | Not done | 1 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | moderate | 20 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Screening | Not done | 1 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | severe | 10 Participants |
| Active Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | normal | 22 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | severe | 17 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Screening | Not done | 0 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Screening | normal | 13 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Screening | mild | 4 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Screening | moderate | 24 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Screening | severe | 28 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | Not done | 1 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | normal | 20 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | mild | 6 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | moderate | 19 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 1 | severe | 23 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | Not done | 1 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | normal | 24 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | mild | 9 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | severe | 14 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | Not done | 1 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | normal | 25 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | mild | 10 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | moderate | 18 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 7 | severe | 13 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | Not done | 0 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | normal | 23 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | mild | 9 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Follow-up | moderate | 18 Participants |
| Sham Treatment | Patient Global Impression of Severity (PGI-S) | Visit 3 | moderate | 20 Participants |
Secondary
Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period | 27 Participants |
| Sham Treatment | Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period | 19 Participants |
p-value: 0.1615Chi-squared
Secondary
Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period | 32 Participants |
| Sham Treatment | Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period | 17 Participants |
p-value: 0.0102Chi-squared
Secondary
Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period | 16 Participants |
| Sham Treatment | Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period | 9 Participants |
p-value: 0.13Chi-squared
Secondary
Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period | 20 Participants |
| Sham Treatment | Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period | 11 Participants |
p-value: 0.0798Chi-squared