Trial Outcomes & Findings for Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents (NCT NCT04089761)

Results Overview

Number of Participants with Device-Related Adverse Events

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-02-25

Participant Flow

Study design Run-in: participants reported their migraine attacks, headache level and associated symptoms during a 4-weeks period. Treatment phase: Participants used the Nerivio device for the treatment of migraine attacks during a period of up to 8-week. participants reported their migraine attacks, headache level and associated symptoms. follow up (optional): Participants were asked to incorporate the Nerivio into their standard care according to their preferences.

Participant milestones

Participant milestones
Measure	Active Device Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
"Run In" Phase STARTED	60
"Run In" Phase COMPLETED	45
"Run In" Phase NOT COMPLETED	15
"Treatment" Phase STARTED	45
"Treatment" Phase COMPLETED	39
"Treatment" Phase NOT COMPLETED	6
"Follow Up" Phase (Optional) STARTED	27
"Follow Up" Phase (Optional) COMPLETED	27
"Follow Up" Phase (Optional) NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Device Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
"Run In" Phase Not eligible to proceed to the treatment phase	14
"Run In" Phase Lost to Follow-up	1
"Treatment" Phase No evaluable data	5
"Treatment" Phase Lost to Follow-up	1

Baseline Characteristics

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Device n=60 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Age, Categorical <=18 years	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.4 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Average number of headache days per month	9.6 Days per month STANDARD_DEVIATION 4.6 • n=5 Participants
Migraine with aura	19 Participants n=5 Participants
Triptan usage	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All subjects who entered to the treatment phase

Number of Participants with Device-Related Adverse Events

Outcome measures

Outcome measures
Measure	Active Device n=45 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Safety of Nerivio Device	1 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

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

Outcome measures

Outcome measures
Measure	Active Device n=39 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Pain Relief at 2 Hours Post Treatment	28 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

The percentage of subjects reporting, for the test treatment, no pain at 2 hours post-treatment without the use of rescue medication. Pain-free is defined as improvement from mild, moderate, or severe pain to no pain. Pain level was reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)

Outcome measures

Outcome measures
Measure	Active Device n=39 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Pain-free at 2 Hours Post Treatment	14 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

Population: Only 22 subjects reported to have nausea at baseline (T=0 hours)

The percentage of subjects presented nausea at the baseline (T=0 hours) and reported disappearance of nausea at 2 hours post-treatment of the test treatment

Outcome measures

Outcome measures
Measure	Active Device n=22 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Disappearance of Nausea at 2 Hours Post-treatment	12 Participants

SECONDARY outcome

Timeframe: 2 hors post treatment

Population: Only 31 subjects reported to have photophobia at baseline (T=0 hours)

The percentage of subjects presented photophobia at baseline (T=0 hours) and reported disappearance of photophobia at 2 hours post-treatment of the test treatment

Outcome measures

Outcome measures
Measure	Active Device n=31 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Disappearance of Photophobia at 2 Hours Post Treatment	13 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

Population: Only 25 subjects reported to have phonophobia at baseline (T=0 hours)

The percentage of subjects presented phonophobia at baseline (T=0 hours) and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment

Outcome measures

Outcome measures
Measure	Active Device n=25 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Disappearance of Phonophobia at 2 Hours Post Treatment	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours post treatment

Population: Only 22 of the 28 subjects with pain relief at T=2 hours reported their headache level at 24 hours

The percentage of subjects achieving, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours

Outcome measures

Outcome measures
Measure	Active Device n=22 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Sustained Pain Relief at 24 Hours Post Treatment	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours post treatment

Population: Only 11 of the 14 subjects with freedom from pain at T=2 hours reported their headache level at 24 hours

The percentage of subjects achieving, for the test treatment, freedom from pain at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours

Outcome measures

Outcome measures
Measure	Active Device n=11 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Sustained Pain Free at 24 Hours Post Treatment	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours post treatment

Population: Only 33 of the 35 subjects reported their functional disability score at both T=0 hours and T=2 hours

The percentage of subjects achieving improvement of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication

Outcome measures

Outcome measures
Measure	Active Device n=33 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Functional Disability at 2 Hours Post Treatment	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours post treatment

Population: Only 29 of the 35 subjects reported their functional disability score at both T=0 hours and T=24 hours

The percentage of subjects achieving improvement of at least one grade in functional disability in the test treatment at 24 hours post-treatment with no use of rescue medication

Outcome measures

Outcome measures
Measure	Active Device n=29 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Functional Disability at 24 Hours Post Treatment	20 Participants

POST_HOC outcome

Timeframe: 8 weeks

parcentage of subjects achieving pain relief at 2 hours in at least 50% of all their treatments

Outcome measures

Outcome measures
Measure	Active Device n=39 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Within-subject Consistency of the Pain Relief Response	26 Participants

POST_HOC outcome

Timeframe: 8 weeks

percentage of subjects achieving freedom from pain at 2 hours in at least 50% of all their treatments

Outcome measures

Outcome measures
Measure	Active Device n=39 Participants Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Within-subject Consistency of the Freedom From Pain Response	13 Participants

Adverse Events

Active Device

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Device n=45 participants at risk Treatment of acute migraine with an active form of Nerivio device Nerivio: Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Nervous system disorders Pain in the arm	2.2% 1/45 • Number of events 1 • 12 weeks
Reproductive system and breast disorders Common Cold	2.2% 1/45 • Number of events 1 • 12 weeks
Respiratory, thoracic and mediastinal disorders chest congestion	4.4% 2/45 • Number of events 2 • 12 weeks
Respiratory, thoracic and mediastinal disorders Influenza	4.4% 2/45 • Number of events 2 • 12 weeks
General disorders Leg pain	2.2% 1/45 • Number of events 1 • 12 weeks
Infections and infestations streptococcus pharyngitis	2.2% 1/45 • Number of events 1 • 12 weeks
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	2.2% 1/45 • Number of events 1 • 12 weeks
Nervous system disorders Worsen migraine	2.2% 1/45 • Number of events 1 • 12 weeks

Additional Information

Dr Dagan Harris. VP Clinical and Regulatory Affairs

Theranica Bio-Electronics Ltd

Phone: +972723909755

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place