Trial Outcomes & Findings for A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache. (NCT NCT01958125)
NCT ID: NCT01958125
Last Updated: 2019-02-26
Results Overview
Headache pain was collected at the beginning of the attack (all treated attacks) and 15 minutes post treatment pain free attacks. Data was collected in the patient diary.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
gammaCore
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
COMPLETED
|
48
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
gammaCore
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Overall Study
Missing diary data
|
2
|
6
|
|
Overall Study
No headache attacks
|
0
|
2
|
Baseline Characteristics
A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.
Baseline characteristics by cohort
| Measure |
gammaCore
n=50 Participants
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=52 Participants
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
Total
n=102 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
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 10.63 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: ITT-Intention To Treat population
Headache pain was collected at the beginning of the attack (all treated attacks) and 15 minutes post treatment pain free attacks. Data was collected in the patient diary.
Outcome measures
| Measure |
gammaCore
n=48 Participants
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=44 Participants
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment
Number of treated attacks
|
495 Number of attacks
|
400 Number of attacks
|
|
Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment
Number of treated attack pain free at 15 minutes
|
67 Number of attacks
|
46 Number of attacks
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Safety population, three patients in the Sham device group have no data
Mean difference of scores on a 5 step disability scale. Disability was measured at baseline and after the randomization phase (2 weeks later). Lowest score is 1 and is better than the higher score at 5 that is the worst. An increase, higher scores, means worsening. 1. minor 2. minor/moderate 3. moderate 4. moderate/severe 5. severe
Outcome measures
| Measure |
gammaCore
n=50 Participants
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=49 Participants
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline
Disability score at baseline
|
3.9 units on a scale
Standard Error 0.2
|
3.7 units on a scale
Standard Error 0.2
|
|
Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline
Disability score at 2 weeks
|
3.3 units on a scale
Standard Error 0.2
|
3.2 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Safety population, three patients in the Sham group had no data for EQ-5D-3L
EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, activity, pain and anxiety. Each dimension has 3 levels: 1 = no problems, 2 = moderate problems, 3=extreme problems. Subjects indicate health state by ticking choosing appropriate statement in each dimension and a VAS scale (Overall health) from 0-100 mm where higher score is better (100) than lower score (0). Patients completed the EQ-5D-3L at baseline (the start of the randomized period and at 2 weeks).
Outcome measures
| Measure |
gammaCore
n=50 Participants
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=49 Participants
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Mobility at baseline
|
1.2 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Mobility after 2 weeks
|
1.3 units on a scale
Standard Error 0.1
|
1.1 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Selfcare after 2 weeks
|
1.1 units on a scale
Standard Error 0
|
1.1 units on a scale
Standard Error 0
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Activity baseline
|
1.7 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Activity after 2 weeks
|
1.6 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Pain at baseline
|
2.1 units on a scale
Standard Error 0.1
|
1.9 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Pain after 2 weeks
|
1.7 units on a scale
Standard Error 0.1
|
1.8 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Anxiety at baseline
|
1.5 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Anxiety after 2 weeks
|
1.3 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
VAS scale at baseline
|
58.9 units on a scale
Standard Error 2.5
|
63.7 units on a scale
Standard Error 2.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
VAS scale after 2 weeks
|
61.4 units on a scale
Standard Error 2.5
|
66.5 units on a scale
Standard Error 2.1
|
|
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Selfcare at baseline
|
1.1 units on a scale
Standard Error 0
|
1.1 units on a scale
Standard Error 0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT-Intention To Treat population
Following treatment at 15 minutes, patients recorded use of any rescue medication(s) in the diary'
Outcome measures
| Measure |
gammaCore
n=48 Participants
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=44 Participants
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Patients Who Used Any Type of Rescue Medication
|
40 participants
|
42 participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT-Intention To Treat population
The headache pain was collected at the beginning of the attack and 30 minutes post treatment in the patient diary. The number of pain free (no pain) attacks are compared to all attacks treated
Outcome measures
| Measure |
gammaCore
n=48 Participants
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=44 Participants
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment
Number of attacks treated
|
495 Number of attacks
|
400 Number of attacks
|
|
Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment
Number of attacks treated and pain free at 30 min.
|
101 Number of attacks
|
81 Number of attacks
|
Adverse Events
gammaCore
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Sham Device
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
gammaCore
n=50 participants at risk
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=52 participants at risk
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Gastrointestinal disorders
Left lower pain abdominal
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Psychiatric disorders
Depressed and anxious
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 2 • 2 weeks
diaries and open questions
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
Other adverse events
| Measure |
gammaCore
n=50 participants at risk
Active Comparator: gammacore gammacore active device to be used noninvasively to the vagal nerve in the neck
|
Sham Device
n=52 participants at risk
Placebo Comparator: inactive gammacore same as the active treatment, but without the therapy treatment provided
|
|---|---|---|
|
Eye disorders
Visual impairment
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Abdominal pain lowe
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Regurgitation
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
General disorders
Application site irritation
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
General disorders
Application site paraesthesia
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
General disorders
Application site vesicles
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
General disorders
Facial pain
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
General disorders
Fatigue
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
General disorders
Local swelling
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Nervous system disorders
Typical aura without headache
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.00%
0/50 • 2 weeks
diaries and open questions
|
1.9%
1/52 • Number of events 1 • 2 weeks
diaries and open questions
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
3.8%
2/52 • Number of events 2 • 2 weeks
diaries and open questions
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.0%
1/50 • Number of events 1 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
|
Skin and subcutaneous tissue disorders
Skin sensitisation
|
4.0%
2/50 • Number of events 2 • 2 weeks
diaries and open questions
|
0.00%
0/52 • 2 weeks
diaries and open questions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60