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This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine attacks
Period 1: 4-week observational run-in period; no stimulation treatment. Subjects use standard of care (SoC) medication to treat their migraine attacks, according to their individual prescriptions.
Period 2: 4-week randomized/controlled period. After the run-in period, subjects are randomized (1:1) to receive either an nVNS device or a sham device to treat up to 5 migraine attacks.
Period 3: 4-week open-label (active treatment) period. After the randomized period, subjects continue to the open-label period where all subjects receive an active gammaCore device to treat up to 5 migraine attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gammaCore-S | Active Comparator | Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve |
|
| gammaCore-S Sham | Sham Comparator | Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gammaCore-S | Device | At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Response - No Pain | The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment. | 2 hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia | Presence or absence of nausea/vomiting, photophobia and phonophobia for nVNS and sham therapies for the first treated migraine attack at 120 minutes during study Period 2. | 2 hours post-treatment study - period 2 (each study period was 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 3 | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Number of migraine attacks with treatment response 'no pain' for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Period 3. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Tassorelli, MD, PhD | IRCSS "National Neurological Institute C. Mondino" Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Aldo Moro, Ospedale Pediatrico | Bari | Italy | ||||
| IRCCS Istituto delle Scienze Neurologiche di Bologna, Ospedale Bellaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30382909 | Derived | Martelletti P, Barbanti P, Grazzi L, Pierangeli G, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Tassorelli C, Liebler E, de Tommaso M; PRESTO Study Group. Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Nov 1;19(1):101. doi: 10.1186/s10194-018-0929-0. | |
| 30340460 |
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37 patients were excluded from the study at the end of the 4-week Run-In/Observational period because they did not continue to meet the study eligibility criteria, were lost to follow-up, or they chose not to continue in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | gammaCore-S | Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication. |
| FG001 | gammaCore-S Sham | Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-In Period 1 |
|
| |||||||||||||||||||||
| Randomized Controlled Period 2 |
| ||||||||||||||||||||||
| Open Label Period 3 |
|
ITT Population, n=243
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| ID | Title | Description |
|---|---|---|
| BG000 | gammaCore-S | Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment Response - No Pain | The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment. | Sensitivity analysis, Intent to Treat population | Posted | Count of Participants | Participants | 2 hours post-treatment |
|
12 weeks - Period 1 (4 weeks), Period 2 (4 weeks) and Period 3 (4 weeks)
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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 | gammaCore-S | Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | electroCore INC | +1 973 355 6683 | clinical@electrocore.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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|
|
| gammaCore-S Sham | Device | At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication. |
|
|
| Number of Participants With Treatment Response - No Pain or Mild Pain |
Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Results show count of participants with a response of no pain (score = 0) or mild pain (score = 1) on the 4-point headache pain scale for the nVNS and sham therapies at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment for the first treated migraine attack during study Period 2. |
| 2 hours post-treatment |
| Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours. | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Results show count of participants with a response of no pain or mild pain on the 4-point headache pain scale at 24, and 48 hours post-treatment (and no rescue medication use) for nVNS and sham therapies for the first treated migraine attack during study Period 2. | 24 and 48 hours post-treatment |
| Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Results show % Treatment response 'No pain' for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Period 2. | 30, 60, 120 minutes; Study Period 2 (each study period was 4 weeks) |
| 30, 60, 120 minutes; Period 3 (each study period was 4 weeks) |
| Number of Migraine Attacks With Treatment Response no Pain or Mild Pain | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Number of migraine attacks with treatment response 'no pain' or 'mild pain' on the 4-point headache pain scale for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Periods 2 and 3 (separately) | 30, 60, 120 minutes; Study Periods 2 and 3 (each study period was 4 weeks) |
| Number of Migraine Attacks With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Number of Attacks with Absence of Nausea, Vomiting, Photophobia and Phonophobia at 120 minutes for nVNS and sham therapies calculated for all treated attacks during study Periods 2 and 3 (separately). | Study Periods 2 and 3 (each study period was 4 weeks) |
| Number of Attacks With Sustained Treatment Response | Number of migraine attacks with sustained treatment response (mild or no pain at 24 and 48 hours post-treatment) for nVNS and sham therapies calculated for all treated attacks during study Periods 2 and 3 (separately). | 24 and 48 hours; Study Periods 2 and 3 (each study period was 4 weeks) |
| Number of Subjects With Consistency of Response | Consistency of response, defined as the number of subjects who achieve no pain or mild pain in 50% or greater of their attacks, in subjects treating at least two attacks, for nVNS and sham therapies for all treated attacks during study Periods 2 and 3 (separately). | Study Periods 2 and 3 (each study period was 4 weeks) |
| Quality of Life Measured by EuroQol-5D-5L (EQ-5D-5L) | Treatment effect on quality of life: EQ-5D-5L is assessed at end of the run-in period and at the end of each 4-week period for nVNS and sham therapies. EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1 = no problems, 2 = slight problems, 3= moderate problems, 4 = severe problems and 5 = extreme problems. Subjects indicate health state by ticking choosing appropriate statement in each dimension. The 5 dimensions scores are combined into a score, where a lower score indicates less problems. Scores across all 5 dimensions are averaged resulting in a total theoretical score of 1 to 5 with lower scores indicating less problems | End of each study period (each study period was 4 weeks) |
| Bang Blinding Index Scores | After the first treated attack and at the end of the double blind period (period 2) subjects were asked to guess if they were had received 'gammaCore-S', ''sham' or 'do not know'. Bang blinding index estimated are presented for the gammaCore-S and sham. Bang Blinding Index shows the success of blinding. The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding. A score of one means they guess correctly, -1 incorrectly. If the bang index includes 0 it indicates that the guesses were consistent for the sham and active and the study was appropriately blinded | Study Period 2 (4 weeks) |
| Subject Satisfaction | Subject satisfaction with the study devices Subjects were asked to rate their satisfaction with the device from the following options: Extremely satisfied, Very satisfied, Satisfied, A little satisfied or Not at all satisfied | End of Study Periods 2 and 3 (each study period was 4 weeks long) |
| Mean Change in Pain Score From Baseline to 120 Minutes | Subjects rated pain at onset of migraine attack (baseline) and at 120 minutes using a 4 point headache pain scale where 0 = no pain, 1 = mild pain, 3 = moderate pain and 4 = severe pain. A lower score indicates less pain. Mean change in pain score from baseline to 120 minutes for all attacks in study period 2 | 120 minutes, Study Period 2 (each study period was 4 weeks long) |
| Ease of Use | Ease of use of the study devices - Subjects were asked to rate the ease of use of the device from the following options: Very easy, somewhat easy, difficult, very difficult. | End of Study Periods 2 and 3 (each study period was 4 weeks long) |
| Quality of Life Measured by Headache Impact Test (HIT-6) | The HIT-6 measures impact of headaches on ability to function at work, at home and in social situations. Subjects answer 6 questions about ability to function and normal daily life and for each question they rate the impact of their headaches as 'never' (6 points) or 'rarely' (9 points) or 'sometimes' (10 points) or 'very often' (11 points) or 'always' (13 points). Minimum score = 36, maximum score = 78. Higher score is worse and lower score is better quality of life | End of each study period (each study period was 4 weeks) |
| Bologna |
| Italy |
| University Hospital of Careggi | Florence | Italy |
| Fondazione IRCCS Istituto Neurologico C. Besta | Milan | Italy |
| IRCSS "National Neurological Institute C. Mondino" Foundation | Pavia | Italy |
| S. Maria della Misericordia Hospital | Perugia | Italy |
| INM Neuromed IRCCS | Pozzilli | Italy |
| IRCCS San Raffaele Pisana | Rome | Italy |
| Sant'Andrea Hospital, Sapienza University of Rome | Rome | Italy |
| University of Turin | Turin | Italy |
| Derived |
| Grazzi L, Tassorelli C, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Oct 19;19(1):98. doi: 10.1186/s10194-018-0928-1. |
| 29907608 | Derived | Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15. |
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | gammaCore-S Sham | Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Age of Onset of Migraine Attacks | Mean | Standard Deviation | years |
|
| Migraine with Aura Diagnosis | Count of Participants | Participants |
|
| Number of Migraine Attacks Per Month in Last 6 Months | Mean | Standard Deviation | Attacks per month |
|
| Days Per Month Acute Migraine Medication Taken | Mean | Standard Deviation | Days per month |
|
| Currently Taking Migraine Prevention Medication | Count of Participants | Participants |
|
| OG001 | gammaCore-S Sham | Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication. |
|
|
| Secondary | Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia | Presence or absence of nausea/vomiting, photophobia and phonophobia for nVNS and sham therapies for the first treated migraine attack at 120 minutes during study Period 2. | Intent to treat population | Posted | Count of Participants | Participants | 2 hours post-treatment study - period 2 (each study period was 4 weeks) |
|
|
|
| Secondary | Number of Participants With Treatment Response - No Pain or Mild Pain | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Results show count of participants with a response of no pain (score = 0) or mild pain (score = 1) on the 4-point headache pain scale for the nVNS and sham therapies at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment for the first treated migraine attack during study Period 2. | Intent to Treat | Posted | Count of Participants | Participants | 2 hours post-treatment |
|
|
|
| Secondary | Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours. | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Results show count of participants with a response of no pain or mild pain on the 4-point headache pain scale at 24, and 48 hours post-treatment (and no rescue medication use) for nVNS and sham therapies for the first treated migraine attack during study Period 2. | Intent to Treat | Posted | Count of Participants | Participants | 24 and 48 hours post-treatment |
|
|
|
| Secondary | Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Results show % Treatment response 'No pain' for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Period 2. | Intent to Treat | Posted | Count of Units | Attacks | 30, 60, 120 minutes; Study Period 2 (each study period was 4 weeks) | Attacks | Attacks |
|
|
|
| Other Pre-specified | Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 3 | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Number of migraine attacks with treatment response 'no pain' for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Period 3. | Intent to Treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated | Posted | Count of Units | Attacks | 30, 60, 120 minutes; Period 3 (each study period was 4 weeks) | Attacks | Attacks |
|
|
|
| Other Pre-specified | Number of Migraine Attacks With Treatment Response no Pain or Mild Pain | Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain. Number of migraine attacks with treatment response 'no pain' or 'mild pain' on the 4-point headache pain scale for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Periods 2 and 3 (separately) | Intent to Treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated | Posted | Count of Units | Attacks | 30, 60, 120 minutes; Study Periods 2 and 3 (each study period was 4 weeks) | Attacks | Attacks |
|
|
|
| Other Pre-specified | Number of Migraine Attacks With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Number of Attacks with Absence of Nausea, Vomiting, Photophobia and Phonophobia at 120 minutes for nVNS and sham therapies calculated for all treated attacks during study Periods 2 and 3 (separately). | Intent to Treat population Period 2 373/347 attacks treated Period 3 286/309 attacks treated | Posted | Count of Units | Attacks | Study Periods 2 and 3 (each study period was 4 weeks) | Attacks | Attacks |
|
|
|
| Other Pre-specified | Number of Attacks With Sustained Treatment Response | Number of migraine attacks with sustained treatment response (mild or no pain at 24 and 48 hours post-treatment) for nVNS and sham therapies calculated for all treated attacks during study Periods 2 and 3 (separately). | Intent to treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated | Posted | Count of Units | Attacks | 24 and 48 hours; Study Periods 2 and 3 (each study period was 4 weeks) | Attacks | Attacks |
|
|
|
| Other Pre-specified | Number of Subjects With Consistency of Response | Consistency of response, defined as the number of subjects who achieve no pain or mild pain in 50% or greater of their attacks, in subjects treating at least two attacks, for nVNS and sham therapies for all treated attacks during study Periods 2 and 3 (separately). | Intent to Treat | Posted | Number | participants | Study Periods 2 and 3 (each study period was 4 weeks) |
|
|
|
| Other Pre-specified | Quality of Life Measured by EuroQol-5D-5L (EQ-5D-5L) | Treatment effect on quality of life: EQ-5D-5L is assessed at end of the run-in period and at the end of each 4-week period for nVNS and sham therapies. EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1 = no problems, 2 = slight problems, 3= moderate problems, 4 = severe problems and 5 = extreme problems. Subjects indicate health state by ticking choosing appropriate statement in each dimension. The 5 dimensions scores are combined into a score, where a lower score indicates less problems. Scores across all 5 dimensions are averaged resulting in a total theoretical score of 1 to 5 with lower scores indicating less problems | Intent to treat | Posted | Mean | Standard Deviation | Score | End of each study period (each study period was 4 weeks) |
|
|
|
| Other Pre-specified | Bang Blinding Index Scores | After the first treated attack and at the end of the double blind period (period 2) subjects were asked to guess if they were had received 'gammaCore-S', ''sham' or 'do not know'. Bang blinding index estimated are presented for the gammaCore-S and sham. Bang Blinding Index shows the success of blinding. The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding. A score of one means they guess correctly, -1 incorrectly. If the bang index includes 0 it indicates that the guesses were consistent for the sham and active and the study was appropriately blinded | Intent to treat | Posted | Number | 95% Confidence Interval | Bang Blinding Index Score | Study Period 2 (4 weeks) |
|
|
|
| Other Pre-specified | Subject Satisfaction | Subject satisfaction with the study devices Subjects were asked to rate their satisfaction with the device from the following options: Extremely satisfied, Very satisfied, Satisfied, A little satisfied or Not at all satisfied | Intent to treat | Posted | Count of Participants | Participants | End of Study Periods 2 and 3 (each study period was 4 weeks long) |
|
|
|
| Other Pre-specified | Mean Change in Pain Score From Baseline to 120 Minutes | Subjects rated pain at onset of migraine attack (baseline) and at 120 minutes using a 4 point headache pain scale where 0 = no pain, 1 = mild pain, 3 = moderate pain and 4 = severe pain. A lower score indicates less pain. Mean change in pain score from baseline to 120 minutes for all attacks in study period 2 | Intent to Treat | Posted | Mean | 95% Confidence Interval | score on a scale | 120 minutes, Study Period 2 (each study period was 4 weeks long) |
|
|
|
| Other Pre-specified | Ease of Use | Ease of use of the study devices - Subjects were asked to rate the ease of use of the device from the following options: Very easy, somewhat easy, difficult, very difficult. | Intent to treat | Posted | Count of Participants | Participants | End of Study Periods 2 and 3 (each study period was 4 weeks long) |
|
|
|
| Other Pre-specified | Quality of Life Measured by Headache Impact Test (HIT-6) | The HIT-6 measures impact of headaches on ability to function at work, at home and in social situations. Subjects answer 6 questions about ability to function and normal daily life and for each question they rate the impact of their headaches as 'never' (6 points) or 'rarely' (9 points) or 'sometimes' (10 points) or 'very often' (11 points) or 'always' (13 points). Minimum score = 36, maximum score = 78. Higher score is worse and lower score is better quality of life | Intent to treat | Posted | Mean | Standard Deviation | Score | End of each study period (each study period was 4 weeks) |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 22 |
| 122 |
| EG001 | gammaCore-S Sham | Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication. | 0 | 126 | 0 | 126 | 23 | 126 |
| Ear Pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site discomfort | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site hyperaesthesia | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site rash | General disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Blood pressure | Investigations | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Status migrainosus | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Varicocele repair | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| No Vomiting at 120 minutes |
|
|
| No Photophobia at 120 minutes |
|
|
| No Phonophobia at 120 minutes |
|
|
| 120 Minutes |
|
| 120 Minutes |
|
|
| Period 2 60 Minutes |
|
|
| Period 2 120 Minutes |
|
|
| Period 3 30 Minutes |
|
|
| Period 3 60 Minutes |
|
|
| Period 3 120 Minutes |
|
|
|
| No Vomiting Period 2 |
|
|
| No Photophobia Period 2 |
|
|
| No Phonophobia Period 2 |
|
|
| No Nausea Period 3 |
|
|
| No Vomiting Period 3 |
|
|
| No Photophobia Period 3 |
|
|
| No Phonophobia Period 3 |
|
|
|
| 48 Hours, Period 2 |
|
|
| 24 Hours, Period 3 |
|
|
| 48 Hours, Period 3 |
|
|
| Period 3 |
|
|
| EQ5D5L - Visit 3 End of run-in period |
|
|
| EQ5D5L -Visit 5 End of randomised period |
|
|
| EQ5D5L - Visit 7 End of open label period |
|
|
| Visit 5 Satisfied |
|
| Visit 5 A Little Satisfied |
|
| Visit 5 Not at All Satisfied |
|
| Visit 7 Extremely Satisfied |
|
| Visit 7 Very Satisfied |
|
| Visit 7 Satisfied |
|
| Visit 7 A Little Satisfied |
|
| Visit 7 Not at All Satisfied |
|
| Visit 5 Easy |
|
|
| Visit 5 Difficult |
|
|
| Visit 5 Very Difficult |
|
|
| Visit 7 Very Easy |
|
|
| Visit 7 Easy |
|
|
| Visit 7 Difficult |
|
|
| Visit 7 Very Difficult |
|
|
| HIT6 - Visit 3 End of run-in period |
|
|
| HIT6 - Visit 5 End of randomised period |
|
|
| HIT6 - Visit 7 End of open label period |
|
|