Trial Outcomes & Findings for Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN) (NCT NCT06138756)
NCT ID: NCT06138756
Last Updated: 2025-09-15
Results Overview
Incidence of device-related adverse events reported by subjects throughout the study period
COMPLETED
293 participants
Up to 6 months
2025-09-15
Participant Flow
Participant milestones
| Measure |
Pre-adolescents With Migraine
Patients at the age of 6-11 (included) with migraines who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Overall Study
STARTED
|
293
|
|
Overall Study
COMPLETED
|
293
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Based on the number of participant for each age category
Baseline characteristics by cohort
| Measure |
Pre-adolescents With Migraine
n=293 Participants
Patients at the age of 6-11 (included) with migraines who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Age, Customized
11<= and <12 years
|
151 Participants
n=293 Participants
|
|
Age, Customized
10<= and <11 years
|
68 Participants
n=293 Participants
|
|
Age, Customized
9<= and <10 years
|
34 Participants
n=293 Participants
|
|
Age, Customized
8<= and <9 years
|
26 Participants
n=293 Participants
|
|
Age, Customized
7<= and <8 years
|
11 Participants
n=293 Participants
|
|
Age, Customized
6<= and <7 years
|
3 Participants
n=293 Participants
|
|
Sex/Gender, Customized
Female (<=11 and <12 years)
|
114 Participants
n=151 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Female (<=10 Age <11 years)
|
52 Participants
n=68 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Female (<=9 and <10 years)
|
21 Participants
n=34 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Female (<=8 and <9 years)
|
17 Participants
n=26 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Female (<=7 and <8)
|
10 Participants
n=11 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Female (<=6 and <7 years)
|
2 Participants
n=3 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Male (<=11 and <12 years)
|
37 Participants
n=151 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Male (<=10 and <11 years)
|
16 Participants
n=68 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Male (<=9 and <10 years)
|
13 Participants
n=34 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Male (<=8 and <9 years)
|
9 Participants
n=26 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Male (<=7 and <8 years)
|
1 Participants
n=11 Participants • Based on the number of participant for each age category
|
|
Sex/Gender, Customized
Male (<=6 and <7 years)
|
1 Participants
n=3 Participants • Based on the number of participant for each age category
|
PRIMARY outcome
Timeframe: Up to 6 monthsIncidence of device-related adverse events reported by subjects throughout the study period
Outcome measures
| Measure |
Pre-adolescence With Migraine
n=293 Participants
Patients at the age of 6-11 (included) with migraine who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Rate of Device Related Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.
Outcome measures
| Measure |
Pre-adolescence With Migraine
n=18 Participants
Patients at the age of 6-11 (included) with migraine who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Consistent Headache Relief at 2 Hours Post-treatment
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later
Outcome measures
| Measure |
Pre-adolescence With Migraine
n=25 Participants
Patients at the age of 6-11 (included) with migraine who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Consistent Freedom From Headache at 2 Hours Post-treatment
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
The proportion of subjects reporting the presence of each of the migraine-associated symptoms (nausea/vomiting, photophobia, phonophobia) at the beginning of treatment and reported their absence 2 hours following the treatment in at least 50% of their attacks.
Outcome measures
| Measure |
Pre-adolescence With Migraine
n=11 Participants
Patients at the age of 6-11 (included) with migraine who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
Nausea/vomiting
|
7 Participants
|
|
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
Photophobia
|
2 Participants
|
|
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
Phonophobia
|
4 Participants
|
|
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
At least one symptom
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.
Outcome measures
| Measure |
Pre-adolescence With Migraine
n=18 Participants
Patients at the age of 6-11 (included) with migraine who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Consistent Functional Disability Relief at 2 Hours Post-treatment
|
15 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.
Outcome measures
| Measure |
Pre-adolescence With Migraine
n=18 Participants
Patients at the age of 6-11 (included) with migraine who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
|
|---|---|
|
Consistent Functional Disability Disappearance at 2 Hours Post-treatment
|
7 Participants
|
Adverse Events
Pre-adolescence With Migraine
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