Trial Outcomes & Findings for Acute Treatment of Migraine With e-TNS (NCT NCT02590939)
NCT ID: NCT02590939
Last Updated: 2018-06-06
Results Overview
Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
1 hour
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Active Device
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
47
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Active Device
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Failed the nociceptive test
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.71 years
STANDARD_DEVIATION 13.62 • n=52 Participants
|
40.09 years
STANDARD_DEVIATION 12.65 • n=54 Participants
|
39.90 years
STANDARD_DEVIATION 13.14 • n=106 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=52 Participants
|
49 Participants
n=54 Participants
|
92 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=52 Participants
|
5 Participants
n=54 Participants
|
14 Participants
n=106 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Migraine type
Migraine with aura
|
12 Participants
n=52 Participants
|
5 Participants
n=54 Participants
|
17 Participants
n=106 Participants
|
|
Migraine type
Migraine without aura
|
40 Participants
n=52 Participants
|
49 Participants
n=54 Participants
|
89 Participants
n=106 Participants
|
|
Migraine duration (hours)
|
7 hours
n=52 Participants
|
6 hours
n=54 Participants
|
6 hours
n=106 Participants
|
|
Use of acute medication before enrollment
|
17 Participants
n=52 Participants
|
14 Participants
n=54 Participants
|
31 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: 1 hourMean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Pain Score 1-hour
|
-59 percent change
Standard Deviation 35
|
-30 percent change
Standard Deviation 31
|
PRIMARY outcome
Timeframe: 1 hourMean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Pain Score 1-hour
|
-3.46 units on a scale
Standard Deviation 2.32
|
-1.78 units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 2 hoursNumber of patients not having required rescue medication at 2 hours
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Rescue Medication 2 Hours
Patients having used rescue medication at 2 hours
|
3 Participants
|
2 Participants
|
|
Rescue Medication 2 Hours
Patients not having used rescue medication at 2 h
|
44 Participants
|
50 Participants
|
|
Rescue Medication 2 Hours
Patients for whom med data was not available
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 hoursMean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Pain Score 2 Hours
|
-50 percent change
Standard Deviation 36
|
-32 percent change
Standard Deviation 37
|
SECONDARY outcome
Timeframe: 24 hoursNumber of patients not having required rescue medication within 24 hours
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Rescue Medication 24 Hours
Patients having used rescue medication within 24 h
|
18 Participants
|
21 Participants
|
|
Rescue Medication 24 Hours
Patients not having used rescue med within 24h
|
27 Participants
|
30 Participants
|
|
Rescue Medication 24 Hours
Patients for whom med data was not available
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hoursMean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Pain Score 24 Hours
|
-57 percent change
Standard Deviation 37
|
-40 percent change
Standard Deviation 40
|
SECONDARY outcome
Timeframe: 2 hoursMean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Pain Score 2 Hours
|
-2.87 units on a scale
Standard Deviation 2.24
|
-1.85 units on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 24 hoursMean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)
Outcome measures
| Measure |
Active Device
n=52 Participants
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 Participants
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Pain Score 24 Hours
|
-3.46 units on a scale
Standard Deviation 2.65
|
-2.38 units on a scale
Standard Deviation 2.27
|
Adverse Events
Active Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Device
n=52 participants at risk
60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation
|
Sham Device
n=54 participants at risk
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
|
|---|---|---|
|
Nervous system disorders
Nausea
|
1.9%
1/52 • Number of events 1 • 24 hours following the beginning of the treatment
|
0.00%
0/54 • 24 hours following the beginning of the treatment
|
Additional Information
Clinical Trials Department director
CEFALY Technology
Phone: +32 4 367 67 22
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 60 days from the time submitted to the sponsor for review. Sponsor may request: * deletion of any trade secret, proprietary, or confidential information of Sponsor * an additional 90 days to take measures to preserve its IP rights Sponsor cannot require editorial changes. Sponsor's consent is required for results communication before trial completion
- Publication restrictions are in place
Restriction type: OTHER