Trial Outcomes & Findings for Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache (NCT NCT01792817)
NCT ID: NCT01792817
Last Updated: 2019-12-17
Results Overview
The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group. A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.
COMPLETED
NA
150 participants
15 minutes post stimulation
2019-12-17
Participant Flow
Participant milestones
| Measure |
Sham GammaCore Device
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
GammaCore Open Label
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|---|
|
Phase 1 Double Blind Period
STARTED
|
77
|
73
|
0
|
|
Phase 1 Double Blind Period
COMPLETED
|
58
|
42
|
0
|
|
Phase 1 Double Blind Period
NOT COMPLETED
|
19
|
31
|
0
|
|
Phase 2 Open Label
STARTED
|
0
|
0
|
100
|
|
Phase 2 Open Label
COMPLETED
|
0
|
0
|
74
|
|
Phase 2 Open Label
NOT COMPLETED
|
0
|
0
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
Baseline characteristics by cohort
| Measure |
Sham GammaCore Device
n=77 Participants
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device
n=73 Participants
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Height
|
69.8 inches
STANDARD_DEVIATION 3.84 • n=5 Participants
|
69.4 inches
STANDARD_DEVIATION 3.62 • n=7 Participants
|
69.6 inches
STANDARD_DEVIATION 3.73 • n=5 Participants
|
|
Weight
|
193 pounds
STANDARD_DEVIATION 37.79 • n=5 Participants
|
189.5 pounds
STANDARD_DEVIATION 40.79 • n=7 Participants
|
191.3 pounds
STANDARD_DEVIATION 39.19 • n=5 Participants
|
|
CH Type
Episodic
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
CH Type
Chronic
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Taking CH Prevention Medicaiton
|
60 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Full Time Employment
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes post stimulationPopulation: Intent to treat study population
The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group. A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.
Outcome measures
| Measure |
Sham GammaCore Device
n=77 Participants
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device
n=73 Participants
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|
|
Number of Participants With Repsonse to Treatment
Responder
|
14 Participants
|
16 Participants
|
|
Number of Participants With Repsonse to Treatment
Non-responder
|
57 Participants
|
44 Participants
|
|
Number of Participants With Repsonse to Treatment
Missing
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: For 1 hour post stimulationSustained treatment success at 1 hour post-treatment was defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 15 minutes and 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1, and having refrained from use of rescue medications during the full 60 minute period
Outcome measures
| Measure |
Sham GammaCore Device
n=77 Participants
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device
n=73 Participants
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|
|
Sustained Treatment Success at 1 Hour Post-Treatment
Yes
|
9 Participants
|
16 Participants
|
|
Sustained Treatment Success at 1 Hour Post-Treatment
No
|
63 Participants
|
44 Participants
|
|
Sustained Treatment Success at 1 Hour Post-Treatment
Missing
|
5 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 15 minutes post-stimulationPopulation: There were 4 subjects with no data in the Sham GammaCore group and 13 subject in the GammaCore group.
Cluster headache attack intensity was reported on a 5-point scale: no pain, mild, moderate, severe, very severe, whereas no pain =1 is the best outcome and very severe=5 is the worst outcome . The average of all subjects' mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group. The mean 15-minute scores were calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available were averaged.
Outcome measures
| Measure |
Sham GammaCore Device
n=73 Participants
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device
n=60 Participants
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|
|
Average Mean Attack Intensities Experienced Per Subject
|
2.0 Score on a scale
Standard Deviation 0.9
|
2.1 Score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: 4 weeks, Phase 1The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study.
Outcome measures
| Measure |
Sham GammaCore Device
n=77 Participants
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device
n=73 Participants
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|
|
Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events.
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
Adverse Events
Sham GammaCore Device (Randomized Period)
GammaCore Device (Randomized Period)
GammaCore Device (Open Label Period)
Serious adverse events
| Measure |
Sham GammaCore Device (Randomized Period)
n=77 participants at risk
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device (Randomized Period)
n=73 participants at risk
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
GammaCore Device (Open Label Period)
n=100 participants at risk
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|---|
|
Gastrointestinal disorders
Mesenteric ischemia
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Nervous system disorders
Hospitalization for cluster headache pain
|
0.00%
0/77
|
1.4%
1/73 • Number of events 2
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Multiple left upper extremity DVT
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Abdominal aortic aneurysm
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Healthcare acquired pneumonia
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anasarca
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Acute respiratory failure
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Injury, poisoning and procedural complications
Urethral trauma
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Left ureteral calculus
|
0.00%
0/77
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
Other adverse events
| Measure |
Sham GammaCore Device (Randomized Period)
n=77 participants at risk
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device: Treatment with sham stimulator
|
GammaCore Device (Randomized Period)
n=73 participants at risk
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
GammaCore Device (Open Label Period)
n=100 participants at risk
Non-Invasive Vagus Nerve Stimulator
GammaCore: Treatment with active gammacore vagus nerve stimulator
|
|---|---|---|---|
|
Product Issues
Burning Sensation during treatment
|
6.5%
5/77 • Number of events 5
|
0.00%
0/73
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Cold/Flu
|
0.00%
0/77
|
0.00%
0/73
|
6.0%
6/100 • Number of events 7
|
|
Product Issues
Dysguesia
|
9.1%
7/77 • Number of events 7
|
0.00%
0/73
|
2.0%
2/100 • Number of events 2
|
|
Product Issues
Erythema
|
11.7%
9/77 • Number of events 9
|
0.00%
0/73
|
2.0%
2/100 • Number of events 2
|
|
Product Issues
Myokymia
|
0.00%
0/77
|
11.0%
8/73 • Number of events 8
|
9.0%
9/100 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60