Trial Outcomes & Findings for Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine (NCT NCT04161807)

Results Overview

The proportion of participants reporting pain relief at 2 hours post-treatment without the use of rescue medication following the test treatment . Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

2 hours post-treatment

Results posted on

2021-02-16

Participant Flow

This study was conducted from September 18, 2019 to February 18, 2020. . Study sites were Nuvance health (Poughkeepsie, NY) and Meir Medical center (Kefar Sava, Israel). 42 patients were enrolled and received a device. Two participants withdrew from the study. All participants completed at least one treatment (the training treatment) and 38 participants completed the test treatment, forming the final analysis set.

Participant milestones

Participant milestones
Measure	Nerivio Device Treatment participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Overall Study STARTED	42
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Nerivio Device Treatment participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Overall Study Withdrawal by Subject	2
Overall Study Performed only 1 treatment	2

Baseline Characteristics

Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nerivio Device Treatment n=42 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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, Continuous	42.1 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Region of Enrollment Israel	12 participants n=5 Participants
Average number of headache days per month	21.5 Days per month STANDARD_DEVIATION 6.3 • n=5 Participants
Average number of migraine headache das per month	18.3 Days per month STANDARD_DEVIATION 6.6 • n=5 Participants
Use of preventive medication	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours post-treatment

The proportion of participants reporting pain relief at 2 hours post-treatment without the use of rescue medication following the test treatment . Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain.

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=38 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment	19 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

The proportion of participants reporting freedom from migraine pain at 2 hours post-treatment without medications following the test treatment. Pain freedom is defined as an improvement from severe or moderate or mild pain to no pain

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=38 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment	10 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

Population: only 17 participants reported nausea and/or vomiting at T=0 hours of the Test treatment

The proportion of participants reporting disappearance of nausea and/or vomiting at 2 hours post-treatment without rescue medications following the test treatment.

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=17 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment	10 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

Population: only 24 participants reported photophobia at T=0 hours of the Test treatment

The proportion of participants reporting disappearance of photophobia at 2 hours post-treatment without rescue medications following the test treatment.

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=24 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment	9 Participants

SECONDARY outcome

Timeframe: 2 hours post treatment

Population: only 16 participants reported phonophobia at T=0 hours of the Test treatment

The proportion of participants reporting disappearance phonophobia at 2 hours post-treatment without rescue medications following the test treatment.

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=16 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Proportions of participants achieving pain relief at 2 hours in at least 50% of all their treatments (excluding the training treatment)

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=38 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments	27 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Proportion of participants achieving pain free at 2 hours in at least 50% of all their treatments (excluding the training treatment)

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=38 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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-patient Consistency - Percentage of Participants Free of Headache Pain in at Least 50% of Their Treatments	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours post treatment

Population: Only 30 participants reported their function disability level at T=0 hours and T=2 hours for their test treatment

The proportion of participants 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. the scale used was: (0) No limitation, (1) Some limitation, (2) Moderate limitation and (3) Severe limitation.

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=30 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Improve Functional Disability at 2 Hours Post-treatment	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours post treatment

Population: Only 19 participants reported their function disability level at T=0 hours and T=24 hours for their test treatment

The proportion of participants 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. the scale used was: (0) No limitation, (1) Some limitation, (2) Moderate limitation and (3) Severe limitation.

Outcome measures

Outcome measures
Measure	Nerivio Device Treatment n=19 Participants participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Proportion of Participants With Improve Functional Disability at 24 Hours Post-treatment	15 Participants

Adverse Events

Nerivio Device Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nerivio Device Treatment n=42 participants at risk participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started Nerivio: 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.
Skin and subcutaneous tissue disorders Tingling	2.4% 1/42 • Number of events 1 • Up to 4 weeks The Nerivio device is a neurostimulator and it is externally applied over the body.The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as theexclusion criteria for the study leave out participant with electrical implant,congenital heart failure or epilepsy, the number of high risk participants is zero.

Additional Information

Dr Dagan Harris. VP Clinical @Regulatory Affairs

Theranica Bio-Electronics Ltd

Phone: 0542220121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place