Trial Outcomes & Findings for Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care (NCT NCT01701245)
NCT ID: NCT01701245
Last Updated: 2016-04-25
Results Overview
The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) - number of CH attacks during run-in.
COMPLETED
PHASE2
97 participants
4 weeks
2016-04-25
Participant Flow
Participant milestones
| Measure |
Standard of Care
No intervention, standard of care
|
GammaCore
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
FAS Unmatched Data
|
48
|
45
|
|
Overall Study
FAS Matched Data
|
42
|
32
|
|
Overall Study
COMPLETED
|
37
|
33
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Standard of Care
No intervention, standard of care
|
GammaCore
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Did not complete the open label period
|
11
|
12
|
Baseline Characteristics
Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
Baseline characteristics by cohort
| Measure |
Standard of Care
n=49 Participants
No intervention, standard of care
|
GammaCore
n=48 Participants
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
45.4 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
43.8 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=99 Participants
|
29 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Full analysis set (FAS), matched group.
The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) - number of CH attacks during run-in.
Outcome measures
| Measure |
Standard of Care
n=48 Participants
No intervention, standard of care
|
GammaCore
n=45 Participants
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
A Change in the Frequency of Cluster Headache Attacks Per Week
|
-2.0 CH attacks per week
Standard Deviation 7.6
|
-7.6 CH attacks per week
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: baseline (2 weeks) and random period(last 2 weeks)Population: Median severity per subject in run in period (14 days) and the last 14 Days in the treatment period. FAS matched data set
The median pain during baseline (2 weeks) will be compared with the last 14 days of the treatment period Scale 0-4 0= no pain 1. mild pain 2. moderate pain 3. severe pain 4. very severe pain
Outcome measures
| Measure |
Standard of Care
n=42 Participants
No intervention, standard of care
|
GammaCore
n=32 Participants
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
Pain Relief of Headache Attacks
Mild baseline
|
2 participants
|
1 participants
|
|
Pain Relief of Headache Attacks
Mild random
|
3 participants
|
1 participants
|
|
Pain Relief of Headache Attacks
Moderate baseline
|
16 participants
|
8 participants
|
|
Pain Relief of Headache Attacks
Moderate random
|
15 participants
|
11 participants
|
|
Pain Relief of Headache Attacks
Severe baseline
|
16 participants
|
15 participants
|
|
Pain Relief of Headache Attacks
Severe random
|
16 participants
|
12 participants
|
|
Pain Relief of Headache Attacks
Very severe baseline
|
8 participants
|
8 participants
|
|
Pain Relief of Headache Attacks
Very severe random
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Safety population The Adverse Device effects are reported as Adverse Event, the device effects are AEs that are considered related to the treatment. Graded mild, moderate and severe
The frequency of device effects will be compared between the two treatment groups. Only effects which are new after baseline or have increased severity after baseline will be used in the comparison.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
No intervention, standard of care
|
GammaCore
n=48 Participants
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
Adverse Events
Mild
|
6 participants
|
9 participants
|
|
Adverse Events
Moderate
|
2 participants
|
1 participants
|
|
Adverse Events
Severe
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks)Population: Changes between baseline and randomized period.Randomized period and open label. FAS Unmatched data.
The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label. Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state
Outcome measures
| Measure |
Standard of Care
n=48 Participants
No intervention, standard of care
|
GammaCore
n=45 Participants
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)
Baseline vs. Randomized period
|
-0.049 units on a scale
Interval -0.837 to 0.856
|
0.145 units on a scale
Interval -0.532 to 0.807
|
|
EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)
Randomized period vs. Open label perios
|
0.078 units on a scale
Interval -0.601 to 1.01
|
0.155 units on a scale
Interval -0.568 to 1.01
|
|
EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)
VAS Baseline vs. Randomized period
|
0.27 units on a scale
Interval -81.0 to 40.0
|
9.20 units on a scale
Interval -20.0 to 40.0
|
|
EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)
VAS Randomized period vs. Open label
|
4.36 units on a scale
Interval -50.0 to 48.0
|
10.79 units on a scale
Interval -26.0 to 55.0
|
Adverse Events
Standard of Care
GammaCore
Serious adverse events
| Measure |
Standard of Care
n=49 participants at risk
No intervention, standard of care
|
GammaCore
n=48 participants at risk
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/49 • 18 months
|
2.1%
1/48 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Scrotal Haematoma
|
0.00%
0/49 • 18 months
|
2.1%
1/48 • Number of events 1 • 18 months
|
|
Infections and infestations
Genital herpes simplex
|
2.0%
1/49 • Number of events 1 • 18 months
|
0.00%
0/48 • 18 months
|
|
Nervous system disorders
Cluster headache
|
2.0%
1/49 • Number of events 1 • 18 months
|
0.00%
0/48 • 18 months
|
Other adverse events
| Measure |
Standard of Care
n=49 participants at risk
No intervention, standard of care
|
GammaCore
n=48 participants at risk
Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
6.1%
3/49 • Number of events 3 • 18 months
|
6.2%
3/48 • Number of events 3 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place