Trial Outcomes & Findings for Real-world Data Analysis of REN Treatment in Adolescence With Migraine (NCT NCT05443659)

NCT ID: NCT05443659

Last Updated: 2025-11-04

Results Overview

The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)

• Recruitment status: COMPLETED
• Target enrollment: 1629 participants
• Primary outcome timeframe: 2 hours post treatment, up to 16 months from the 1st treatment
• Results posted on: 2025-11-04

Participant Flow

Participant milestones

Measure	Nerivio Users Age 12-18 Adolecents with migraine who used theNerivio REN device for treating theitr migraine
Overall Study STARTED	1629
Overall Study COMPLETED	1629
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The age was calculated once per all study participants following by a subanalysis for each gender

Baseline characteristics by cohort

Measure	Nerivio Users Age 12-18 n=1629 Participants Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Age, Continuous Age, All	15.9 years STANDARD_DEVIATION 1.3 • n=1629 Participants • The age was calculated once per all study participants following by a subanalysis for each gender
Age, Continuous Age, female	15.8 years STANDARD_DEVIATION 1.1 • n=1313 Participants • The age was calculated once per all study participants following by a subanalysis for each gender
Age, Continuous Age, Male	16.0 years STANDARD_DEVIATION 1.7 • n=258 Participants • The age was calculated once per all study participants following by a subanalysis for each gender
Age, Continuous Age, not identified	16.1 years STANDARD_DEVIATION 1.9 • n=58 Participants • The age was calculated once per all study participants following by a subanalysis for each gender
Sex/Gender, Customized Female	1313 Participants n=1629 Participants
Sex/Gender, Customized Male	258 Participants n=1629 Participants
Sex/Gender, Customized Not identifies	58 Participants n=1629 Participants

PRIMARY outcome

Timeframe: 2 hours post treatment, up to 16 months from the 1st treatment

Population: REN users at the age of 12-=18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and repoerted baseline headache of moderate or severe in T=0h

The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)

Outcome measures

Measure	Nerivio Users Age 12-18 n=262 Participants Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Consistent Pain Relief at 2 Hours Post-treatment	158 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment, up to 16 months from the 1st treatment

Population: REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and reported a type of headache in T=0h and no headache in the T=2h questionnaire

The proportion of subjects reporting freedom from pain at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain freedom is defined as reduction from severe or moderate or mild pain to no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)

Outcome measures

Measure	Nerivio Users Age 12-18 n=289 Participants Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Consistent Pain Freedom at 2 Hours Post-treatment	76 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment, up to 16 months from the 1st treatment

Population: REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) or with a combination of Nerivio and rescue medication or without any treatment at all and had at least two evaluable treatments (with data at T=0h and T=2h)

The proportion of subjects with REN treatments without the use of pharmacological migraine abortive (rescue) medication (either over the counter or prescribed), or with a combination of rescue medication or without any treatment at all at 2 hours post-treatment in at least 50% of all their treatments.

Outcome measures

Measure	Nerivio Users Age 12-18 n=2365 Treatments with reportad medication Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Consistent Usage of Migraine Abortive (Rescue) Medications Treatments with Nerivio only	1524 Treatments with reportad medication
Consistent Usage of Migraine Abortive (Rescue) Medications Treatments with Nerivio and OTC medications	439 Treatments with reportad medication
Consistent Usage of Migraine Abortive (Rescue) Medications reatments with Nerivio andTriptan Rx	180 Treatments with reportad medication
Consistent Usage of Migraine Abortive (Rescue) Medications reatments with Nerivio and other Rx	222 Treatments with reportad medication

SECONDARY outcome

Timeframe: 2 hours post treatment, up to 16 months from the 1st treatment

Population: REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and reported a reduction of at least one grade in the functional disability scale at T=2h

The proportion of subjects reporting Functional Disability (FD) relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. FD relief is defined as an improvement from severe or moderate limitation to some or no limitation. FD level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation)

Outcome measures

Measure	Nerivio Users Age 12-18 n=255 Participants Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Consistent Functional Disability Relief at 2 Hours Post-treatment	159 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment, up to 16 months from the 1st treatment

Population: REN users at the age of 12-18 who used the Nerivio device as a single therapy (without rescue treatments were used) and had at least two evaluable treatments (with data at T=0h and T=2h) and had a score of at least 1 in the functional disability scale and reported no functional disability at T=2h

The proportion of subjects reporting no Functional Disability (FD) at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. FD disappearance is defined as an improvement from severe or moderate or limitation to no limitation. FD level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation).

Outcome measures

Measure	Nerivio Users Age 12-18 n=255 Participants Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Consistent Functional Disability Disappearance at 2 Hours Post-treatment	155 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 45 minutes post treatment, up to 16 months from the 1st treatment

Population: Nerivio users at the age of 12-18 who treated at least once with the Nerivio device

The mean intensity of the stimulation collected for all treatments that were performed within the study

Outcome measures

Measure	Nerivio Users Age 12-18 n=13681 Nerivio treatments Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Treatment Intensity Distribution Intensity level 16-20	2274 Nerivio treatments
Treatment Intensity Distribution Intensity level 21-25	2492 Nerivio treatments
Treatment Intensity Distribution Intensity level 26-30	2203 Nerivio treatments
Treatment Intensity Distribution Intensity level 1-5	22 Nerivio treatments
Treatment Intensity Distribution Intensity level 6-10	250 Nerivio treatments
Treatment Intensity Distribution Intensity level 11-15	1678 Nerivio treatments
Treatment Intensity Distribution Intensity level 31-35	1661 Nerivio treatments
Treatment Intensity Distribution Intensity level 36-40	1033 Nerivio treatments
Treatment Intensity Distribution Intensity level 41-45	687 Nerivio treatments
Treatment Intensity Distribution Intensity level 46-50	529 Nerivio treatments
Treatment Intensity Distribution Intensity level 51-55	264 Nerivio treatments
Treatment Intensity Distribution Intensity level 56-60	210 Nerivio treatments
Treatment Intensity Distribution Intensity level 61-65	115 Nerivio treatments
Treatment Intensity Distribution Intensity level 66-70	79 Nerivio treatments
Treatment Intensity Distribution Intensity level 71-75	33 Nerivio treatments
Treatment Intensity Distribution Intensity level 76-80	38 Nerivio treatments
Treatment Intensity Distribution Intensity level 81-85	30 Nerivio treatments
Treatment Intensity Distribution Intensity level 86-90	29 Nerivio treatments
Treatment Intensity Distribution Intensity level 91-95	19 Nerivio treatments
Treatment Intensity Distribution tensity level 96-100	35 Nerivio treatments

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 16 months

Population: Nerivio users at the age of 12-18 who used the device at least once

Incidence of device-related adverse events reported by subjects

Outcome measures

Measure	Nerivio Users Age 12-18 n=1629 Participants Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Device Related Adverse Events	3 Participants

Adverse Events

Nerivio Users Age 12-18

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nerivio Users Age 12-18 n=1629 participants at risk Adolecents with migraine who used the nerivio REN device for treating theitr migraine
Skin and subcutaneous tissue disorders Tingling	0.12% 2/1629 • Number of events 2 • up to 18 months
Nervous system disorders Arm soreness	0.06% 1/1629 • Number of events 1 • up to 18 months

Additional Information

Dr Dagan Harris, VP Clinical and Regulatory Affairs

Theranica

Phone: +972542220121

Email: daganh@theranica.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place