Trial Outcomes & Findings for Migraine Treatment With Nerivio Migra Neurostimulation Device (NCT NCT03076515)
NCT ID: NCT03076515
Last Updated: 2025-07-17
Results Overview
Percentage of participants reporting pain relief from pain (pain reduction from 3 or 2 to 1 or 0 or pain reduction from 1 to 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
2 hours post treatment
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
Nerivio Migra Active
Nerivio Migra neurostimulation: transcutaneous electrical stimulation
|
Nerivio Migra Placebo
Sham Nerivio Migra: electrical stimulation- shame mode
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
62
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
25
|
29
|
Reasons for withdrawal
| Measure |
Nerivio Migra Active
Nerivio Migra neurostimulation: transcutaneous electrical stimulation
|
Nerivio Migra Placebo
Sham Nerivio Migra: electrical stimulation- shame mode
|
|---|---|---|
|
Overall Study
DMC decision based on interim analysis
|
25
|
29
|
Baseline Characteristics
Migraine Treatment With Nerivio Migra Neurostimulation Device
Baseline characteristics by cohort
| Measure |
Nerivio Migra Active
n=33 Participants
Nerivio Migra neurostimulation: transcutaneous electrical stimulation
|
Nerivio Migra Placebo
n=33 Participants
Sham Nerivio Migra: electrical stimulation- shame mode
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Migraine attacks per month
|
4.0 number of migraine attacks per month
STANDARD_DEVIATION 1.2 • n=5 Participants
|
3.9 number of migraine attacks per month
STANDARD_DEVIATION 1.3 • n=7 Participants
|
4.0 number of migraine attacks per month
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post treatmentPercentage of participants reporting pain relief from pain (pain reduction from 3 or 2 to 1 or 0 or pain reduction from 1 to 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks
Outcome measures
| Measure |
Nerivio Migra Active
n=33 Participants
Subjects received an active form of Nerivio Migra neurostimulation device
|
Nerivio Migra Placebo
n=33 Participants
Subjects received a Sham form of Nerivio Migra: neurostimulation device
|
|---|---|---|
|
Percentage of Participants With Pain Relief 2 Hours Post Treatment
|
36.3 percentage of responded participants
|
27.2 percentage of responded participants
|
Adverse Events
Nerivio Migra Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nerivio Migra Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place