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The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic migraine, and to support the development and approval of a larger pivotal study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GammaCore Active Device | Active Comparator | Subjects will use an Active GammaCore Device |
|
| GammaCore Sham Device | Sham Comparator | Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaCore Active Device | Device |
| ||
| GammaCore Sham Device |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of Participants With Adverse Events | Safety was assessed by collecting Adverse Effects | Up to 8 weeks - duration of the Randomized period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Headache Days | Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period. | Run-in period (4 weeks no treatment) and Randomized period (8 weeks) |
| Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Headache Center | San Francisco | California | 94143 | United States | ||
| Michigan Head Pain & Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27412146 | Derived | Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR; EVENT Study Group. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016 Aug 2;87(5):529-38. doi: 10.1212/WNL.0000000000002918. Epub 2016 Jul 13. |
| Label | URL |
|---|---|
| Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | GammaCore Active Device | Subjects will use an Active GammaCore Device GammaCore Active Device |
| FG001 | GammaCore Sham Device | Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. |
| FG002 | No Treatment (run-in, Enrollment Period) | The run-in period was 1 month, Subject who did not fulfill the inclusion and/or exclusion criteria was not randomized to the treatment groups |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in (no Treatment) |
| |||||||||||||
| Randomised Period |
|
Randomized population
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| ID | Title | Description |
|---|---|---|
| BG000 | GammaCore Active Device | Subjects will use an Active GammaCore Device GammaCore Active Device |
| BG001 | GammaCore Sham Device | Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. |
| 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 | Safety - Number of Participants With Adverse Events | Safety was assessed by collecting Adverse Effects | Randomized population | Posted | Count of Participants | Participants | Up to 8 weeks - duration of the Randomized period |
|
Up to 8 weeks - duration of the Randomized period
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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 Active Device | Subjects will use an Active GammaCore Device GammaCore Active Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Headache Pain | Nervous system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered sensations (brain zaps) | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | electroCore LLC | +1 973 355 6683 | clinical@electrocorellc.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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| Device |
|
Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe. |
| Run-in (4 weeks no treatment) and Randomized (8 weeks) |
| Use of Pain Relief Medication | All abortive headache medication taken during randomized period | Randomized period - 8 weeks |
| Mean Change in Quality of Life Short Form Survey (SF-12) | The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8. | Run-in (4 weeks) and Randomized period (8 weeks) |
| Ann Arbor |
| Michigan |
| 48104 |
| United States |
| Headache Care Center | Springfield | Missouri | 65807 | United States |
| Montefiore Headache Center | The Bronx | New York | 10461 | United States |
| Carolina Headache Institute | Chapel Hill | North Carolina | 27516 | United States |
| Thomas Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Change in Headache Days | Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period. | Data missing for 1 subject in each treatment group | Posted | Mean | Standard Deviation | days | Run-in period (4 weeks no treatment) and Randomized period (8 weeks) |
|
|
|
| Secondary | Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe | Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe. | Randomized population | Posted | Number | Headache days | Run-in (4 weeks no treatment) and Randomized (8 weeks) |
|
|
|
| Secondary | Use of Pain Relief Medication | All abortive headache medication taken during randomized period | Randomized population | Posted | Count of Participants | Participants | Randomized period - 8 weeks |
|
|
|
| Secondary | Mean Change in Quality of Life Short Form Survey (SF-12) | The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8. | Randomized period | Posted | Mean | Standard Deviation | Score on a scale | Run-in (4 weeks) and Randomized period (8 weeks) |
|
|
|
| 0 |
| 30 |
| 2 |
| 30 |
| 6 |
| 30 |
| EG001 | GammaCore Sham Device | Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. | 0 | 29 | 0 | 29 | 5 | 29 |
| Appendicitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Migratory Paresthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Right arm (hand) tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Right eye twitching | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Lip twiching | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Intermittent Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Exacerbated migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Lip numbness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Blister at treatment site | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| General malaise | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Atypical migraine pain with associated blackouts | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sore throat | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rash at treatment site | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Mild pains in head and right arm | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Itching | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Worsening of migraine | Nervous system disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Blisters at treatment site | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Rash/Blister at treatment site | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Redness at treatment site | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
| Severe migraine | Nervous system disorders | MedDRA | Non-systematic Assessment | Open label - phase 3 |
|
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| D009422 | Nervous System Diseases |
| Run-in Severe |
|
| Randomized Mild |
|
| Randomized Moderate |
|
| Randomized Severe |
|
| Subjects with no data |
|
| Randomized period PCS scores 8 weeks |
|
| Run-in MCS scores |
|
| Randomized period MCS scores 4 weeks |
|
| Randomized period MCS scores 8 weeks |
|