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Trial record 4 of 5 for:    gammacore + prevention of migraine

A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378844
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Migraine
Interventions Device: gammaCore®-R
Device: gammaCore®-R Sham
Enrollment 477
Recruitment Details  
Pre-assignment Details  
Arm/Group Title gammaCore®-R gammaCore®-R Sham Not Randomized
Hide Arm/Group Description

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects that were screen failures and were not randomized
Period Title: Run-in Period
Started 169 172 136
Completed 165 167 0
Not Completed 4 5 136
Period Title: Randomized Period (Double Blind)
Started 165 167 0
Completed 142 135 0
Not Completed 23 32 0
Period Title: Open Label Period
Started 142 135 0
Completed 99 87 0
Not Completed 43 48 0
Arm/Group Title gammaCore®-R gammaCore®-R Sham Total
Hide Arm/Group Description

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Total of all reporting groups
Overall Number of Baseline Participants 165 167 332
Hide Baseline Analysis Population Description
Randomized population, Intention to Treat (ITT)
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 167 participants 332 participants
43.5  (11.11) 41.4  (12.26) 42.4  (11.73)
[1]
Measure Description: Year of inclusion minus date of birth
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 167 participants 332 participants
Female
142
  86.1%
138
  82.6%
280
  84.3%
Male
23
  13.9%
29
  17.4%
52
  15.7%
[1]
Measure Description: Sex, male or female, reported at time of inclusion in study
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 165 participants 167 participants 332 participants
Caucasian
160
  97.0%
154
  92.2%
314
  94.6%
Black
0
   0.0%
2
   1.2%
2
   0.6%
Asian
1
   0.6%
3
   1.8%
4
   1.2%
Other
4
   2.4%
8
   4.8%
12
   3.6%
[1]
Measure Description: Ethnicity recorded at time of inclusion into study
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants 167 participants 332 participants
Greece 15 16 31
Netherlands 15 16 31
Belgium 11 11 22
Norway 6 6 12
Denmark 17 16 33
United Kingdom 43 48 91
Germany 36 32 68
Spain 22 22 44
[1]
Measure Description: Numbers of enrolled subjects per country
1.Primary Outcome
Title Change in the Number of Migraine Days
Hide Description Change in number of migraine days (as reported in subject diary), comparing the 4 week run-in period to the last 4 weeks in the randomized period.
Time Frame last 4 weeks of the randomized/controlled period compared to the subject's own 4-week run-in period.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population, Intention to Treat (ITT)
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
-1.98  (3.031) -1.53  (3.090)
2.Secondary Outcome
Title Number of Participants With 50% Responder Rate
Hide Description The number of subjects with a reduction of 50% or more in number of migraine days (as reported in the subject diary) from the run-in period to the last 4 weeks of the double-blind period.
Time Frame The last four weeks in the randomization period compared to the four week run-in period.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population, Intention to Treat (ITT)
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Measure Type: Count of Participants
Unit of Measure: Participants
47
  28.5%
38
  22.8%
3.Secondary Outcome
Title Mean Change in Number of Headache Days
Hide Description The mean change in number of headache days (as reported in the subject diary) from the run-in period to the last 4 weeks of the double-blind period.
Time Frame The last four weeks in the randomization period compared to the four week run-in period.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population, Intention to Treat (ITT)
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: Days
-2.28  (3.623) -1.72  (3.732)
4.Secondary Outcome
Title Change in Number of Acute Medication Days
Hide Description The mean change in number of acute medication days (as reported in the subject diary) from the run-in period to the last 4 weeks of the double-blind period
Time Frame The last four weeks in the randomization period compared to the four week run-in period.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population, Intention to Treat (ITT)
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (Standard Deviation)
Unit of Measure: acute medication days
-1.65  (3.310) -1.02  (3.310)
5.Secondary Outcome
Title Change in Headache Disability Using Headache Impact Test-6
Hide Description Change in headache disability from the 4 week run-in period to the last 4 weeks of the randomized period as measured using the Headache Impact Test-6 (HIT-6). The HIT-6 measures the impact if a subject's headaches on their ability to function at work, at home and in social situations. Subjects are presented with 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. A higher score indicates more impact.
Time Frame From four week run-in period to last four weeks in the randomization period
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population, Intention to Treat (ITT) In the active group 23 subjects had missing data, in the sham group 32 subjects had missing data at the end of the randomized period
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (Full Range)
Unit of Measure: units on a scale
HIT-6 score Run-in perio Number Analyzed 165 participants 167 participants
63.442
(49 to 74)
64.263
(44 to 76)
HIT-6 score end of Randomized period Number Analyzed 142 participants 135 participants
60.234
(42 to 76)
60.992
(40 to 78)
6.Secondary Outcome
Title Number of Participants According to Grade on the Migraine Disability Assessment (MIDAS) Before and After Randomized Period
Hide Description

Migraine Disability Assessment (MIDAS) score from the end of run-in period to the end of randomized period. The MIDAS assessment measures the effect of headaches on a subject's daily functioning. It takes into account the past 3 months and is comprised of five questions. A lower score indicated less disability, a higher score indicates more disability. The scores are graded:

0-5, MIDAS Grade I, little disability 6-10, MIDAS Grade II, mild disability 11 to 20 MIDAS Grade III, moderate disability 21+ MIDAS Grade IV, severe disability

Time Frame 3 months - end of run-in period to end of randomized period
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized population, Intention to Treat (ITT) At randomisation (visit 2) subject numbers are 165 gammaCore-R and 167 gammaCore-R Sham.

At visit 6 the numbers are lower due to early subject discontinuation: 141 gammaCore-R and 132 gammaCore-R Sham

Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Measure Type: Number
Unit of Measure: participants
Week 0 of Randomized Period (Visit 2) Grade I Number Analyzed 165 participants 167 participants
11 11
Week 0 of Randomized Period (Visit 2) Grade II Number Analyzed 165 participants 167 participants
15 15
Week 0 of Randomized Period (Visit 2) Grade III Number Analyzed 165 participants 167 participants
23 32
Week 0 of Randomized Period (Visit 2) Grade IV Number Analyzed 165 participants 167 participants
116 109
Week 12 (Visit 6) Grade I Number Analyzed 141 participants 132 participants
22 24
Week 12 (Visit 6) Grade II Number Analyzed 141 participants 132 participants
19 17
Week 12 (Visit 6) Grade III Number Analyzed 141 participants 132 participants
37 27
Week 12 (Visit 6) Grade IV Number Analyzed 141 participants 132 participants
63 64
7.Secondary Outcome
Title Compare Changes in Quality of Life EuroQol Questionnaire 5 Dimensions and 5 Levels (EQ-5D-5L)
Hide Description

The descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Each dimension has 5 levels (5L): no problems (1) , slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5).

Minimum score is 5 (no problems) and maximum score is 25 (extreme problems)

An overall health question is asked using a visual analogue scale(VAS) from 0-100 where 0 is bad health and 100 good health

Time Frame From four week run-in period to last four weeks in the randomization period
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population, Intention to Treat (ITT) In the active group 24 subjects had missing data, in the sham group 35 subjects had missing data at the end of the randomized period
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (Full Range)
Unit of Measure: scores on a scale
Mobility run-in period Number Analyzed 165 participants 167 participants
1.10
(1 to 4)
1.10
(1 to 3)
Mobility randomized period Number Analyzed 141 participants 132 participants
1.09
(1 to 3)
1.07
(1 to 3)
Selfcare run-in period Number Analyzed 165 participants 167 participants
1.02
(1 to 4)
1
(1 to 1)
Selfcare randomized period Number Analyzed 141 participants 132 participants
1.02
(1 to 3)
1.02
(1 to 3)
Usual activities run-in period Number Analyzed 165 participants 167 participants
1.27
(1 to 5)
1.23
(1 to 4)
Usual activities randomized period Number Analyzed 141 participants 132 participants
1.24
(1 to 3)
1.22
(1 to 3)
Pain/discomfort run-in period Number Analyzed 165 participants 167 participants
1.56
(1 to 5)
1.59
(1 to 5)
Pain/discomfort randomized period Number Analyzed 141 participants 132 participants
1.50
(1 to 4)
1.48
(1 to 4)
Anxiety/depression run-in period Number Analyzed 165 participants 167 participants
1.35
(1 to 4)
1.4
(1 to 5)
Anxiety/depression randomized period Number Analyzed 141 participants 132 participants
1.32
(1 to 3)
1.41
(1 to 5)
Visual analogue scale )VAS) run-in period Number Analyzed 165 participants 167 participants
80.97
(5 to 100)
80.3
(8 to 100)
Visual analogue scale (VAS) randomized period Number Analyzed 141 participants 132 participants
82.46
(38 to 100)
76.35
(30 to 100)
8.Secondary Outcome
Title Change in Migraine Days in the Open Label Period (Adjusted ANCOVA)
Hide Description Change in number of migraine days (as reported in subject diary) during the 6 month open label period compared to the baseline run-in period.
Time Frame The 6 month open-label period compared to the four week run-in period
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population (Intent to treat)
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (Full Range)
Unit of Measure: Days
Migraine days run in period
7.94
(3 to 15)
7.9
(3 to 12.9)
Migraine days open label period
5.75
(0 to 20)
5.7
(0 to 17)
9.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse Effects were collected for all subjects for the duration of the study.
Time Frame up to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title gammaCore®-R gammaCore®-R Sham Not Randomized Open Label
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects that were screen failures and were not randomized.
Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
Overall Number of Participants Analyzed 169 172 136 277
Measure Type: Count of Participants
Unit of Measure: Participants
Serious adverse events
2
   1.2%
1
   0.6%
0
   0.0%
2
   0.7%
Adverse events (non-serious)
74
  43.8%
91
  52.9%
13
   9.6%
118
  42.6%
10.Secondary Outcome
Title Change in Headache Days in the Open Label Period
Hide Description The mean change in number of headache days (as reported in the subject diary) during the open label period compared to the base-line run-in period
Time Frame The 6 month open-label period compared to the four week run-in period
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population (Intent to treat)
Arm/Group Title gammaCore®-R gammaCore®-R Sham
Hide Arm/Group Description:

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Overall Number of Participants Analyzed 165 167
Mean (95% Confidence Interval)
Unit of Measure: Days
-0.55
(-1.08 to -0.02)
-0.51
(-1.02 to -0.00)
Time Frame 40 weeks (run-in 4 weeks, double blind/randomized 12 weeks, open label 24 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title gammaCore®-R gammaCore®-R Sham Not Randomised Open Label
Hide Arm/Group Description

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R Sham: Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Subjects that were screen failures and were not randomized. Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
All-Cause Mortality
gammaCore®-R gammaCore®-R Sham Not Randomised Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/169 (0.00%)      0/172 (0.00%)      0/136 (0.00%)      0/277 (0.00%)    
Hide Serious Adverse Events
gammaCore®-R gammaCore®-R Sham Not Randomised Open Label
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/169 (1.18%)      1/172 (0.58%)      0/136 (0.00%)      2/277 (0.72%)    
Congenital, familial and genetic disorders         
carrier BRCA2 gene, prophylactic surgery: adnex extirpation * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Gastrointestinal disorders         
Admitted because of suspecion of appendicitis * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Gastric Ulcer * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
obstructive syndrom with dyspnea * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Infections and infestations         
Pneumonia * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal Cell Cancer * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Nervous system disorders         
Migraine attack * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Reproductive system and breast disorders         
Surgery for removal cyste and twisted fallopian tube left * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
gammaCore®-R gammaCore®-R Sham Not Randomised Open Label
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/169 (43.79%)      91/172 (52.91%)      13/136 (9.56%)      118/277 (42.60%)    
Blood and lymphatic system disorders         
Lymphadenopathy * 1  0/169 (0.00%)  0 2/172 (1.16%)  2 0/136 (0.00%)  0 1/277 (0.36%)  1
Cardiac disorders         
Angina pectoris * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Arrhythmia * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Palpitations * 1  4/169 (2.37%)  5 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Supraventricular tachycardia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Tachyarrhythmia * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Ear and labyrinth disorders         
Ear discomfort * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Ear pain * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 1/136 (0.74%)  1 2/277 (0.72%)  2
External ear pain * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Tinnitus * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 1/136 (0.74%)  1 1/277 (0.36%)  2
Vertigo * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  2
Vertigo positional * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Endocrine disorders         
Adrenomegaly * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 1/136 (0.74%)  1 0/277 (0.00%)  0
Hypothyroidism * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Eye disorders         
Asthenopia * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Blepharospasm * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  4
Conjunctival irritation * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Eczema eyelids * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Eye pain * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 1/136 (0.74%)  1 0/277 (0.00%)  0
Hypoaesthesia eye * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Photopsia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Vision blurred * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Visual impairment * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Gastrointestinal disorders         
Abdominal pain * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Abdominal pain upper * 1  2/169 (1.18%)  2 2/172 (1.16%)  2 1/136 (0.74%)  1 1/277 (0.36%)  1
Constipation * 1  0/169 (0.00%)  0 1/172 (0.58%)  2 0/136 (0.00%)  0 1/277 (0.36%)  1
Diarrhoea * 1  2/169 (1.18%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 3/277 (1.08%)  3
Dyspepsia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Dysphagia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Food poisoning * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Gastric ulcer * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Gastritis * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Gastroenteritis * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Haemorrhoids * 1  0/169 (0.00%)  0 2/172 (1.16%)  2 0/136 (0.00%)  0 0/277 (0.00%)  0
Nausea * 1  3/169 (1.78%)  3 1/172 (0.58%)  1 0/136 (0.00%)  0 2/277 (0.72%)  2
Paraesthesia oral * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Toothache * 1  2/169 (1.18%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 4/277 (1.44%)  4
Vomiting * 1  2/169 (1.18%)  2 0/172 (0.00%)  0 0/136 (0.00%)  0 4/277 (1.44%)  5
General disorders         
Application site dermatitis * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site discolouration * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site discomfort * 1  6/169 (3.55%)  6 3/172 (1.74%)  3 0/136 (0.00%)  0 2/277 (0.72%)  2
Application site eczema * 1  0/169 (0.00%)  0 2/172 (1.16%)  2 0/136 (0.00%)  0 1/277 (0.36%)  1
Application site erythema * 1  3/169 (1.78%)  4 7/172 (4.07%)  9 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site injury * 1  0/169 (0.00%)  0 2/172 (1.16%)  2 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site irritation * 1  4/169 (2.37%)  4 8/172 (4.65%)  9 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site pain * 1  4/169 (2.37%)  4 7/172 (4.07%)  12 0/136 (0.00%)  0 4/277 (1.44%)  4
Application site pruritus * 1  0/169 (0.00%)  0 1/172 (0.58%)  2 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site rash * 1  1/169 (0.59%)  1 13/172 (7.56%)  14 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site reaction * 1  1/169 (0.59%)  1 2/172 (1.16%)  2 0/136 (0.00%)  0 0/277 (0.00%)  0
Application site swelling * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Fatigue * 1  2/169 (1.18%)  2 2/172 (1.16%)  2 0/136 (0.00%)  0 1/277 (0.36%)  1
Inflammation * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Influenza like illness * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Malaise * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  2
Pain * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Peripheral swelling * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Pyrexia * 1  2/169 (1.18%)  2 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Hypersensitivity * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Infections and infestations         
Application site pustules * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Bacterial infection * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Bronchitis * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Conjunctivitis viral * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Cystitis * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 1/136 (0.74%)  2 1/277 (0.36%)  2
Diarrhoea infectious * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Ear infection * 1  2/169 (1.18%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Gastroenteritis * 1  1/169 (0.59%)  1 4/172 (2.33%)  4 0/136 (0.00%)  0 2/277 (0.72%)  2
Gastroenteritis viral * 1  0/169 (0.00%)  0 2/172 (1.16%)  2 0/136 (0.00%)  0 3/277 (1.08%)  3
Gastrointestinal infection * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 1/136 (0.74%)  1 0/277 (0.00%)  0
Gingival abscess * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Herpes virus infection * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 1/136 (0.74%)  2 0/277 (0.00%)  0
Herpes zoster * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Hordeolum * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Infected bite * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Infectious mononucleosis * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Influenza * 1  11/169 (6.51%)  12 8/172 (4.65%)  8 0/136 (0.00%)  0 10/277 (3.61%)  13
Kidney infection * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Laryngitis * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Lower respiratory tract infection * 1  1/169 (0.59%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 4/277 (1.44%)  4
Nasopharyngitis * 1  22/169 (13.02%)  22 10/172 (5.81%)  10 3/136 (2.21%)  3 18/277 (6.50%)  21
Pharyngitis * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  2
Pharyngitis streptococcal * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Pneumonia * 1  2/169 (1.18%)  2 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Pulpitis dental * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  2
Q fever * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Rectal abscess * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Respiratory tract infection * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 2/277 (0.72%)  2
Respiratory tract infection viral * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Rhinitis * 1  3/169 (1.78%)  3 1/172 (0.58%)  1 0/136 (0.00%)  0 4/277 (1.44%)  4
Scarlet fever * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Sinusitis * 1  0/169 (0.00%)  0 2/172 (1.16%)  2 0/136 (0.00%)  0 3/277 (1.08%)  3
Tooth abscess * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Upper respiratory tract infection * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Urinary tract infection * 1  2/169 (1.18%)  2 0/172 (0.00%)  0 1/136 (0.74%)  1 4/277 (1.44%)  5
Viral infection * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Vulvovaginal candidiasis * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Injury, poisoning and procedural complications         
Contusion * 1  2/169 (1.18%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Fall * 1  1/169 (0.59%)  2 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Foreign body in eye * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Joint injury * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 1/136 (0.74%)  1 0/277 (0.00%)  0
Ligament sprain * 1  1/169 (0.59%)  1 1/172 (0.58%)  3 0/136 (0.00%)  0 1/277 (0.36%)  1
Limb fracture * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Limb injury * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Muscle injury * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Nerve injury * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Post-traumatic neck syndrome * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Splinter * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  2
Tooth injury * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Investigations         
Heart rate irregular * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  2/169 (1.18%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Arthritis * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Arthropathy * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Back pain * 1  0/169 (0.00%)  0 6/172 (3.49%)  6 1/136 (0.74%)  1 4/277 (1.44%)  4
Bursitis * 1  0/169 (0.00%)  0 1/172 (0.58%)  2 0/136 (0.00%)  0 0/277 (0.00%)  0
Limb discomfort * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Muscle contracture * 1  1/169 (0.59%)  2 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Muscle spasms * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Muscle twitching * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  2
Musculoskeletal chest pain * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Musculoskeletal discomfort * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Musculoskeletal pain * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Musculoskeletal stiffness * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Myalgia * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 1/136 (0.74%)  1 3/277 (1.08%)  4
Neck pain * 1  4/169 (2.37%)  4 1/172 (0.58%)  1 0/136 (0.00%)  0 2/277 (0.72%)  2
Pain in extremity * 1  1/169 (0.59%)  1 3/172 (1.74%)  3 0/136 (0.00%)  0 1/277 (0.36%)  1
Pain in jaw * 1  2/169 (1.18%)  2 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Periarthritis * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  2
Rotator cuff syndrome * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Spinal pain * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Synovial cyst * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Temporomandibular joint syndrome * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Tendonitis * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Benign neoplasm * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Neoplasm * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Nervous system disorders         
Aphasia * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Aura * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Disturbance in attention * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Dizziness * 1  6/169 (3.55%)  10 3/172 (1.74%)  5 1/136 (0.74%)  1 6/277 (2.17%)  9
Dysgeusia * 1  1/169 (0.59%)  1 8/172 (4.65%)  9 0/136 (0.00%)  0 2/277 (0.72%)  2
Dyskinesia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Headache * 1  0/169 (0.00%)  0 4/172 (2.33%)  4 0/136 (0.00%)  0 1/277 (0.36%)  1
Hypoaesthesia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  2
Lethargy * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Migraine * 1  3/169 (1.78%)  3 4/172 (2.33%)  5 0/136 (0.00%)  0 3/277 (1.08%)  3
Muscle contractions involuntary * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Myoclonus * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Paraesthesia * 1  0/169 (0.00%)  0 3/172 (1.74%)  3 0/136 (0.00%)  0 1/277 (0.36%)  1
Phantom pain * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 1/136 (0.74%)  1 0/277 (0.00%)  0
Presyncope * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Status migrainosus * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 3/277 (1.08%)  3
Syncope * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 2/277 (0.72%)  2
Pregnancy, puerperium and perinatal conditions         
Pregnancy * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Psychiatric disorders         
Affective disorder * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Anxiety * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 3/277 (1.08%)  3
Bruxism * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Depression * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Dysphemia * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  2
Insomnia * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Panic attack * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Reproductive system and breast disorders         
Breast cyst * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Dysmenorrhoea * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Endometriosis * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Bronchiectasis * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Cough * 1  3/169 (1.78%)  3 2/172 (1.16%)  2 0/136 (0.00%)  0 0/277 (0.00%)  0
Dysphonia * 1  1/169 (0.59%)  1 5/172 (2.91%)  5 0/136 (0.00%)  0 2/277 (0.72%)  2
Dyspnoea * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Nasal congestion * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Nasal polyps * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Oropharyngeal pain * 1  6/169 (3.55%)  6 6/172 (3.49%)  6 0/136 (0.00%)  0 5/277 (1.81%)  5
Rhinitis allergic * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Throat irritation * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Skin and subcutaneous tissue disorders         
Acne * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Acne cystic * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Dermatitis * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Dermatitis atopic * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Dermatitis contact * 1  0/169 (0.00%)  0 3/172 (1.74%)  3 0/136 (0.00%)  0 0/277 (0.00%)  0
Dry skin * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Eczema * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Erythema * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Pruritus * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Pruritus generalised * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Rash * 1  1/169 (0.59%)  1 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Skin discomfort * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Urticaria * 1  1/169 (0.59%)  1 1/172 (0.58%)  4 0/136 (0.00%)  0 0/277 (0.00%)  0
Surgical and medical procedures         
Cyst removal * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Dental implantation * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Dental operation * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Hernia repair * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Hysterectomy * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Oophorectomy * 1  1/169 (0.59%)  1 0/172 (0.00%)  0 0/136 (0.00%)  0 0/277 (0.00%)  0
Papilloma excision * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Preventive surgery * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Skin lesion excision * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Tooth extraction * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 1/277 (0.36%)  1
Tooth repair * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 0/136 (0.00%)  0 1/277 (0.36%)  1
Vascular disorders         
Hypotension * 1  0/169 (0.00%)  0 1/172 (0.58%)  1 0/136 (0.00%)  0 0/277 (0.00%)  0
Labile blood pressure * 1  0/169 (0.00%)  0 0/172 (0.00%)  0 1/136 (0.74%)  1 0/277 (0.00%)  0
1
Term from vocabulary, MedDRA
*
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: NCT02378844    
Other Study ID Numbers: GM-11
First Submitted: February 18, 2015
First Posted: March 4, 2015
Results First Submitted: July 16, 2018
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019