Trial Outcomes & Findings for Non-Invasive Neurostimulation for the Prevention of Chronic Migraine (NCT NCT01667250)
NCT ID: NCT01667250
Last Updated: 2018-06-20
Results Overview
Safety was assessed by collecting Adverse Effects
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Up to 8 weeks - duration of the Randomized period
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
GammaCore Active Device
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
No Treatment (run-in, Enrollment Period)
The run-in period was 1 month, Subject who did not fulfill the inclusion and/or exclusion criteria was not randomized to the treatment groups
|
|---|---|---|---|
|
Run-in (no Treatment)
STARTED
|
0
|
0
|
73
|
|
Run-in (no Treatment)
COMPLETED
|
0
|
0
|
59
|
|
Run-in (no Treatment)
NOT COMPLETED
|
0
|
0
|
14
|
|
Randomised Period
STARTED
|
30
|
29
|
0
|
|
Randomised Period
COMPLETED
|
29
|
28
|
0
|
|
Randomised Period
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
Baseline characteristics by cohort
| Measure |
GammaCore Active Device
n=30 Participants
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 Participants
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
n=5 Participants
|
41.0 years
n=7 Participants
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks - duration of the Randomized periodPopulation: Randomized population
Safety was assessed by collecting Adverse Effects
Outcome measures
| Measure |
GammaCore Active Device
n=30 Participants
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 Participants
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Safety - Number of Participants With Adverse Events
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Run-in period (4 weeks no treatment) and Randomized period (8 weeks)Population: Data missing for 1 subject in each treatment group
Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.
Outcome measures
| Measure |
GammaCore Active Device
n=29 Participants
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=28 Participants
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Mean Change in Headache Days
|
-1.5 days
Standard Deviation 5.92
|
-0.2 days
Standard Deviation 3.52
|
SECONDARY outcome
Timeframe: Run-in (4 weeks no treatment) and Randomized (8 weeks)Population: Randomized population
Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe.
Outcome measures
| Measure |
GammaCore Active Device
n=30 Participants
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 Participants
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Run-in Mild
|
167 Headache days
|
131 Headache days
|
|
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Run-in Moderate
|
297 Headache days
|
330 Headache days
|
|
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Run-in Severe
|
190 Headache days
|
225 Headache days
|
|
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Randomized Mild
|
297 Headache days
|
250 Headache days
|
|
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Randomized Moderate
|
443 Headache days
|
511 Headache days
|
|
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Randomized Severe
|
274 Headache days
|
395 Headache days
|
SECONDARY outcome
Timeframe: Randomized period - 8 weeksPopulation: Randomized population
All abortive headache medication taken during randomized period
Outcome measures
| Measure |
GammaCore Active Device
n=30 Participants
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 Participants
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Use of Pain Relief Medication
Subjects taking abortive medication
|
26 Participants
|
25 Participants
|
|
Use of Pain Relief Medication
Subjects taking no abortive medication
|
3 Participants
|
3 Participants
|
|
Use of Pain Relief Medication
Subjects with no data
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Run-in (4 weeks) and Randomized period (8 weeks)Population: Randomized period
The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8.
Outcome measures
| Measure |
GammaCore Active Device
n=30 Participants
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 Participants
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Mean Change in Quality of Life Short Form Survey (SF-12)
Run-in PCS score
|
40.9 Score on a scale
Standard Deviation 9.62
|
35.6 Score on a scale
Standard Deviation 10.46
|
|
Mean Change in Quality of Life Short Form Survey (SF-12)
Randomized period PCS score 4 weeks
|
44.0 Score on a scale
Standard Deviation 9.25
|
37.5 Score on a scale
Standard Deviation 12.73
|
|
Mean Change in Quality of Life Short Form Survey (SF-12)
Randomized period PCS scores 8 weeks
|
45.3 Score on a scale
Standard Deviation 8.01
|
38.0 Score on a scale
Standard Deviation 10.67
|
|
Mean Change in Quality of Life Short Form Survey (SF-12)
Run-in MCS scores
|
44.5 Score on a scale
Standard Deviation 11.41
|
45.8 Score on a scale
Standard Deviation 10.55
|
|
Mean Change in Quality of Life Short Form Survey (SF-12)
Randomized period MCS scores 4 weeks
|
44.7 Score on a scale
Standard Deviation 10.53
|
45.8 Score on a scale
Standard Deviation 11.71
|
|
Mean Change in Quality of Life Short Form Survey (SF-12)
Randomized period MCS scores 8 weeks
|
46.5 Score on a scale
Standard Deviation 9.95
|
44.3 Score on a scale
Standard Deviation 12.24
|
Adverse Events
GammaCore Active Device
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
GammaCore Sham Device
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GammaCore Active Device
n=30 participants at risk
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 participants at risk
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Nervous system disorders
Worsening of Headache Pain
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Gastrointestinal disorders
Appendicitis
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
Other adverse events
| Measure |
GammaCore Active Device
n=30 participants at risk
Subjects will use an Active GammaCore Device
GammaCore Active Device
|
GammaCore Sham Device
n=29 participants at risk
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
|
|---|---|---|
|
Nervous system disorders
Altered sensations (brain zaps)
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Migratory Paresthesia
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Right arm (hand) tremor
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Right eye twitching
|
6.7%
2/30 • Number of events 2 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Lip twiching
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Ear and labyrinth disorders
Intermittent Vertigo
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Exacerbated migraine
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
6.9%
2/29 • Number of events 2 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Lip numbness
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Blister at treatment site
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Infections and infestations
General malaise
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Atypical migraine pain with associated blackouts
|
0.00%
0/30 • Up to 8 weeks - duration of the Randomized period
|
3.4%
1/29 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
|
Infections and infestations
Sore throat
|
0.00%
0/30 • Up to 8 weeks - duration of the Randomized period
|
3.4%
1/29 • Number of events 2 • Up to 8 weeks - duration of the Randomized period
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/30 • Up to 8 weeks - duration of the Randomized period
|
3.4%
1/29 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/30 • Up to 8 weeks - duration of the Randomized period
|
3.4%
1/29 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Rash at treatment site
|
0.00%
0/30 • Up to 8 weeks - duration of the Randomized period
|
3.4%
1/29 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
|
Musculoskeletal and connective tissue disorders
Mild pains in head and right arm
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Worsening of migraine
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Blisters at treatment site
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Rash/Blister at treatment site
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Redness at treatment site
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
|
Nervous system disorders
Severe migraine
|
3.3%
1/30 • Number of events 1 • Up to 8 weeks - duration of the Randomized period
|
0.00%
0/29 • Up to 8 weeks - duration of the Randomized period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60