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RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks

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ClinicalTrials.gov Identifier: NCT02686034
Recruitment Status : Completed
First Posted : February 19, 2016
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Device: gammaCore-S
Device: gammaCore-S Sham
Enrollment 285
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description

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.

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.

Period Title: Run-In Period 1
Started 142 143
Completed 122 126
Not Completed 20 17
Reason Not Completed
Eligibility             12             10
Withdrawal by Subject             4             3
Lost to Follow-up             4             4
Period Title: Randomized Controlled Period 2
Started 122 126
Completed 117 122
Not Completed 5 4
Reason Not Completed
Lost to Follow-up             1             2
Withdrawal by Subject             3             0
Adverse Event             0             2
Spontaneous reduction in migraines             1             0
Period Title: Open Label Period 3
Started 117 122
Completed 117 121
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title gammaCore-S gammaCore-S Sham Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 120 123 243
Hide Baseline Analysis Population Description
ITT Population, n=243
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 123 participants 243 participants
38.8  (11.00) 39.6  (11.78) 39.2  (11.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 123 participants 243 participants
Female
95
  79.2%
91
  74.0%
186
  76.5%
Male
25
  20.8%
32
  26.0%
57
  23.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 123 participants 243 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
120
 100.0%
123
 100.0%
243
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Italy Number Analyzed 120 participants 123 participants 243 participants
120
 100.0%
123
 100.0%
243
 100.0%
Age of Onset of Migraine Attacks  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 123 participants 243 participants
29.42  (11.20) 28.51  (11.52) 28.96  (11.35)
Migraine with Aura Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 123 participants 243 participants
8
   6.7%
9
   7.3%
17
   7.0%
Number of Migraine Attacks Per Month in Last 6 Months  
Mean (Standard Deviation)
Unit of measure:  Attacks per month
Number Analyzed 120 participants 123 participants 243 participants
5.4  (1.51) 5.4  (1.48) 5.4  (1.49)
Days Per Month Acute Migraine Medication Taken  
Mean (Standard Deviation)
Unit of measure:  Days per month
Number Analyzed 120 participants 123 participants 243 participants
5.6  (1.69) 5.3  (1.66) 5.5  (1.68)
Currently Taking Migraine Prevention Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 123 participants 243 participants
42
  35.0%
35
  28.5%
77
  31.7%
1.Primary Outcome
Title Number of Participants With Treatment Response - No Pain
Hide Description 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.
Time Frame 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Sensitivity analysis, Intent to Treat population
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Count of Participants
Unit of Measure: Participants
36
  30.0%
26
  21.1%
2.Secondary Outcome
Title Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia
Hide Description 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.
Time Frame 2 hours post-treatment study - period 2 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Count of Participants
Unit of Measure: Participants
No Nausea at 120 minutes Number Analyzed 113 participants 116 participants
83
  73.5%
86
  74.1%
No Vomiting at 120 minutes Number Analyzed 113 participants 115 participants
110
  97.3%
109
  94.8%
No Photophobia at 120 minutes Number Analyzed 113 participants 116 participants
76
  67.3%
72
  62.1%
No Phonophobia at 120 minutes Number Analyzed 112 participants 116 participants
75
  67.0%
74
  63.8%
3.Secondary Outcome
Title Number of Participants With Treatment Response - No Pain or Mild Pain
Hide Description

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.

Time Frame 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Count of Participants
Unit of Measure: Participants
62
  51.7%
50
  40.7%
4.Secondary Outcome
Title Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours.
Hide Description

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.

Time Frame 24 and 48 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Count of Participants
Unit of Measure: Participants
24 Hours
46
  38.3%
37
  30.1%
48 Hours
43
  35.8%
33
  26.8%
5.Secondary Outcome
Title Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks
Hide Description

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.

Time Frame 30, 60, 120 minutes; Study Period 2 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Overall Number of Units Analyzed
Type of Units Analyzed: Attacks
373 347
Count of Units
Unit of Measure: Attacks
30 Minutes
43
  11.5%
28
   8.1%
60 Minutes
69
  18.5%
41
  11.8%
120 Minutes
93
  24.9%
66
  19.0%
6.Other Pre-specified Outcome
Title Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 3
Hide Description

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.

Time Frame 30, 60, 120 minutes; Period 3 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 117 122
Overall Number of Units Analyzed
Type of Units Analyzed: Attacks
286 309
Count of Units
Unit of Measure: Attacks
30 Minutes
35
  12.2%
41
  13.3%
60 Minutes
47
  16.4%
61
  19.7%
120 Minutes
63
  22.0%
83
  26.9%
7.Other Pre-specified Outcome
Title Number of Migraine Attacks With Treatment Response no Pain or Mild Pain
Hide Description

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)

Time Frame 30, 60, 120 minutes; Study Periods 2 and 3 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Overall Number of Units Analyzed
Type of Units Analyzed: Attacks
373 347
Count of Units
Unit of Measure: Attacks
Period 2 30 Minutes Number Analyzed 373 Attacks 347 Attacks
149
  39.9%
123
  35.4%
Period 2 60 Minutes Number Analyzed 373 Attacks 347 Attacks
160
  42.9%
130
  37.5%
Period 2 120 Minutes Number Analyzed 373 Attacks 347 Attacks
165
  44.2%
136
  39.2%
Period 3 30 Minutes Number Analyzed 286 Attacks [1]  309 Attacks [2] 
105
  36.7%
122
  39.5%
Period 3 60 Minutes Number Analyzed 286 Attacks [1]  309 Attacks [2] 
117
  40.9%
140
  45.3%
Period 3 120 Minutes Number Analyzed 286 Attacks [1]  309 Attacks [2] 
124
  43.4%
147
  47.6%
[1]
117 participants
[2]
122 participants
8.Other Pre-specified Outcome
Title Number of Migraine Attacks With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Hide Description 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).
Time Frame Study Periods 2 and 3 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population Period 2 373/347 attacks treated Period 3 286/309 attacks treated
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Overall Number of Units Analyzed
Type of Units Analyzed: Attacks
373 347
Count of Units
Unit of Measure: Attacks
No Nausea Period 2 Number Analyzed 373 Attacks 347 Attacks
253
  67.8%
228
  65.7%
No Vomiting Period 2 Number Analyzed 373 Attacks 347 Attacks
342
  91.7%
312
  89.9%
No Photophobia Period 2 Number Analyzed 373 Attacks 347 Attacks
233
  62.5%
202
  58.2%
No Phonophobia Period 2 Number Analyzed 373 Attacks 347 Attacks
223
  59.8%
203
  58.5%
No Nausea Period 3 Number Analyzed 286 Attacks [1]  309 Attacks [2] 
195
  68.2%
226
  73.1%
No Vomiting Period 3 Number Analyzed 286 Attacks [1]  309 Attacks [2] 
268
  93.7%
288
  93.2%
No Photophobia Period 3 Number Analyzed 286 Attacks [1]  309 Attacks [2] 
158
  55.2%
195
  63.1%
No Phonophobia Period 3 Number Analyzed 286 Attacks [1]  309 Attacks [2] 
154
  53.8%
203
  65.7%
[1]
117 participants
[2]
122 participants
9.Other Pre-specified Outcome
Title Number of Attacks With Sustained Treatment Response
Hide Description 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).
Time Frame 24 and 48 hours; Study Periods 2 and 3 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Overall Number of Units Analyzed
Type of Units Analyzed: Attacks
373 347
Count of Units
Unit of Measure: Attacks
24 Hours, Period 2 Number Analyzed 373 Attacks 347 Attacks
132
  35.4%
103
  29.7%
48 Hours, Period 2 Number Analyzed 373 Attacks 347 Attacks
121
  32.4%
95
  27.4%
24 Hours, Period 3 Number Analyzed 286 Attacks [1]  309 Attacks [2] 
100
  35.0%
117
  37.9%
48 Hours, Period 3 Number Analyzed 286 Attacks [1]  309 Attacks [2] 
96
  33.6%
111
  35.9%
[1]
117 participants
[2]
122 participants
10.Other Pre-specified Outcome
Title Number of Subjects With Consistency of Response
Hide Description 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).
Time Frame Study Periods 2 and 3 (each study period was 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Number
Unit of Measure: participants
Period 2 Number Analyzed 120 participants 123 participants
57 46
Period 3 Number Analyzed 117 participants 122 participants
44 44
11.Other Pre-specified Outcome
Title Quality of Life Measured by EuroQol-5D-5L (EQ-5D-5L)
Hide Description

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

Time Frame End of each study period (each study period was 4 weeks)
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Intent to treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 142 143
Mean (Standard Deviation)
Unit of Measure: Score
EQ5D5L - Visit 1 Start of run-in period Number Analyzed 142 participants 143 participants
0.885  (0.1028) 0.912  (0.0969)
EQ5D5L - Visit 3 End of run-in period Number Analyzed 122 participants 126 participants
0.896  (0.0903) 0.917  (0.0980)
EQ5D5L -Visit 5 End of randomised period Number Analyzed 117 participants 122 participants
0.911  (0.0980) 0.926  (0.0951)
EQ5D5L - Visit 7 End of open label period Number Analyzed 117 participants 121 participants
0.923  (0.0924) 0.931  (0.0910)
12.Other Pre-specified Outcome
Title Bang Blinding Index Scores
Hide Description

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

Time Frame Study Period 2 (4 weeks)
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Intent to treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Bang Blinding Index Score
First Treated Attack
0.07
(-0.037 to 0.173)
0.00
(-0.106 to 0.106)
End of Period 2
-0.03
(-0.143 to 0.075)
0.23
(0.125 to 0.334)
13.Other Pre-specified Outcome
Title Subject Satisfaction
Hide Description 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
Time Frame End of Study Periods 2 and 3 (each study period was 4 weeks long)
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Intent to treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 5 Extremely Satisfied
7
   5.8%
8
   6.5%
Visit 5 Very Satisfied
18
  15.0%
12
   9.8%
Visit 5 Satisfied
27
  22.5%
22
  17.9%
Visit 5 A Little Satisfied
33
  27.5%
36
  29.3%
Visit 5 Not at All Satisfied
33
  27.5%
44
  35.8%
Visit 7 Extremely Satisfied
10
   8.3%
12
   9.8%
Visit 7 Very Satisfied
19
  15.8%
18
  14.6%
Visit 7 Satisfied
23
  19.2%
34
  27.6%
Visit 7 A Little Satisfied
32
  26.7%
26
  21.1%
Visit 7 Not at All Satisfied
31
  25.8%
28
  22.8%
14.Other Pre-specified Outcome
Title Mean Change in Pain Score From Baseline to 120 Minutes
Hide Description 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
Time Frame 120 minutes, Study Period 2 (each study period was 4 weeks long)
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Intent to Treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-0.4954
(-0.6509 to -0.3399)
-0.2769
(-0.4392 to -0.1146)
15.Other Pre-specified Outcome
Title Ease of Use
Hide Description 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.
Time Frame End of Study Periods 2 and 3 (each study period was 4 weeks long)
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Hide Analysis Population Description
Intent to treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 120 123
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 5 Very Easy Number Analyzed 118 participants 122 participants
90
  76.3%
97
  79.5%
Visit 5 Easy Number Analyzed 118 participants 122 participants
23
  19.5%
20
  16.4%
Visit 5 Difficult Number Analyzed 118 participants 122 participants
5
   4.2%
4
   3.3%
Visit 5 Very Difficult Number Analyzed 118 participants 122 participants
0
   0.0%
1
   0.8%
Visit 7 Very Easy Number Analyzed 115 participants 118 participants
92
  80.0%
98
  83.1%
Visit 7 Easy Number Analyzed 115 participants 118 participants
18
  15.7%
17
  14.4%
Visit 7 Difficult Number Analyzed 115 participants 118 participants
5
   4.3%
3
   2.5%
Visit 7 Very Difficult Number Analyzed 115 participants 118 participants
0
   0.0%
0
   0.0%
16.Other Pre-specified Outcome
Title Quality of Life Measured by Headache Impact Test (HIT-6)
Hide Description

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

Time Frame End of each study period (each study period was 4 weeks)
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Hide Analysis Population Description
Intent to treat
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 142 143
Mean (Standard Deviation)
Unit of Measure: Score
HIT6 - Visit 1 Start of run-in period Number Analyzed 142 participants 143 participants
63.250  (5.0581) 63.179  (5.2977)
HIT6 - Visit 3 End of run-in period Number Analyzed 122 participants 126 participants
63.275  (5.4618) 61.894  (5.5704)
HIT6 - Visit 5 End of randomised period Number Analyzed 117 participants 122 participants
61.897  (5.5900) 60.959  (5.6604)
HIT6 - Visit 7 End of open label period Number Analyzed 117 participants 121 participants
61.128  (5.5871) 60.750  (5.7149)
Time Frame 12 weeks - Period 1 (4 weeks), Period 2 (4 weeks) and Period 3 (4 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title gammaCore-S gammaCore-S Sham
Hide Arm/Group Description

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.

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.

All-Cause Mortality
gammaCore-S gammaCore-S Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)      0/126 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
gammaCore-S gammaCore-S Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/122 (0.00%)      0/126 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
gammaCore-S gammaCore-S Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/122 (18.03%)      23/126 (18.25%)    
Cardiac disorders     
Tachycardia  1  1/122 (0.82%)  1 0/126 (0.00%)  0
Ear and labyrinth disorders     
Ear Pain  1  1/122 (0.82%)  1 0/126 (0.00%)  0
Vertigo  1  1/122 (0.82%)  1 1/126 (0.79%)  2
Gastrointestinal disorders     
Dysphagia * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Salivary hypersecretion * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Toothache * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
General disorders     
Adverse drug reaction * 1  1/122 (0.82%)  2 0/126 (0.00%)  0
Application site discomfort * 1  3/122 (2.46%)  3 1/126 (0.79%)  1
Application site erythema * 1  0/122 (0.00%)  0 3/126 (2.38%)  5
Application site hyperaesthesia * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Application site pain * 1  0/122 (0.00%)  0 3/126 (2.38%)  4
Application site paraesthesia * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Application site rash * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Chest pain * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Hypothermia * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Pyrexia * 1  2/122 (1.64%)  2 0/126 (0.00%)  0
Infections and infestations     
Acute sinusitis * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Bronchitis * 1  2/122 (1.64%)  2 0/126 (0.00%)  0
Cystitis * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Infection * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Influenza * 1  0/122 (0.00%)  0 3/126 (2.38%)  3
Nasopharyngitis * 1  2/122 (1.64%)  2 3/126 (2.38%)  3
Tooth abscess * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Urinary tract infection * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Investigations     
Blood pressure * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Groin pain * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Muscle spasms * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Neck pain * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Pain in extremity * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Nervous system disorders     
Balance disorder * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Dizziness * 1  0/122 (0.00%)  0 3/126 (2.38%)  4
Migraine * 1  2/122 (1.64%)  2 0/126 (0.00%)  0
Migraine with aura * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Paraesthesia * 1  1/122 (0.82%)  1 1/126 (0.79%)  1
Sciatica * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Status migrainosus * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Dysphonia * 1  0/122 (0.00%)  0 1/126 (0.79%)  1
Epistaxis * 1  2/122 (1.64%)  2 0/126 (0.00%)  0
Hyperventilation * 1  0/122 (0.00%)  0 1/126 (0.79%)  2
Rhinitis allergic * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
Surgical and medical procedures     
Varicocele repair * 1  1/122 (0.82%)  1 0/126 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Affairs
Organization: electroCore INC
Phone: +1 973 355 6683
EMail: clinical@electrocore.com
Layout table for additonal information
Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT02686034     History of Changes
Other Study ID Numbers: GM-16
First Submitted: February 15, 2016
First Posted: February 19, 2016
Results First Submitted: October 3, 2017
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019