Trial Outcomes & Findings for Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine (NCT NCT04194008)
NCT ID: NCT04194008
Last Updated: 2021-02-02
Results Overview
The proportion 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 will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
2 hours post-treatment
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
Nerivio Device Treatment
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Baseline (Run-in) Phase
STARTED
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126
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Baseline (Run-in) Phase
COMPLETED
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99
|
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Baseline (Run-in) Phase
NOT COMPLETED
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27
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Treatment Phase With Nerivio
STARTED
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99
|
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Treatment Phase With Nerivio
COMPLETED
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91
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Treatment Phase With Nerivio
NOT COMPLETED
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8
|
Reasons for withdrawal
| Measure |
Nerivio Device Treatment
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Baseline (Run-in) Phase
Fail to comply with Run-in phase criteria
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19
|
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Baseline (Run-in) Phase
Withdrawal by Subject
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6
|
|
Baseline (Run-in) Phase
Lost to Follow-up
|
2
|
|
Treatment Phase With Nerivio
Withdrawal by Subject
|
3
|
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Treatment Phase With Nerivio
Missing data
|
4
|
|
Treatment Phase With Nerivio
Lost to Follow-up
|
1
|
Baseline Characteristics
Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine
Baseline characteristics by cohort
| Measure |
Nerivio Device Treatment
n=126 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Age, Continuous
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44.3 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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110 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
|
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Average number of headache days per month
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18.8 Days
STANDARD_DEVIATION 2.7 • n=5 Participants
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Average number of migraine headache days per month
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16.4 Days
STANDARD_DEVIATION 3.7 • n=5 Participants
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Use of preventive medication
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80 Participants
n=5 Participants
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|
Migraine with aura
|
36 Participants
n=5 Participants
|
|
Triptan usage
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-treatmentThe proportion 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 will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Outcome measures
| Measure |
Nerivio Device Treatment
n=91 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Pain Relief at 2 Hours Post-treatment
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54 Participants
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SECONDARY outcome
Timeframe: 2 hours post-treatmentThe proportion 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 none. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Outcome measures
| Measure |
Nerivio Device Treatment
n=91 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
|
Pain-free at 2 Hours Post-treatment
|
19 Participants
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SECONDARY outcome
Timeframe: 2 hours post treatmentPopulation: only 41 participants reported nausea at T=0 hours. thus, this is the denominator number for this analysis
The proportion of subjects presented nausea at the migraine onset and reported disappearance of nausea at 2 hours post-treatment of the test treatment
Outcome measures
| Measure |
Nerivio Device Treatment
n=41 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Disappearance of Nausea at 2 Hours Post-treatment
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20 Participants
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SECONDARY outcome
Timeframe: 2 hours post treatmentPopulation: only 74 participants reported photophobia at T=0 hours. thus, this is the denominator number for this analysis
The proportion of subjects presented photohobia at the migraine onset and reported disappearance of photophobia at 2 hours post-treatment of the test treatment
Outcome measures
| Measure |
Nerivio Device Treatment
n=74 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Disappearance of Photophobia at 2 Hours Post-treatment
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30 Participants
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SECONDARY outcome
Timeframe: 2 hours post treatmentPopulation: only 65 participants reported phonophobia at T=0 hours. thus, this is the denominator number for this analysis
The proportion of subjects presented phonophobia at the migraine onset and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment
Outcome measures
| Measure |
Nerivio Device Treatment
n=65 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Disappearance of Phonophobia at 2 Hours Post-treatment
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29 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: throughout the studyproportion of patients achieving pain relief at 2 hours in at least 50% of all their treatments
Outcome measures
| Measure |
Nerivio Device Treatment
n=91 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Within-subject Consistency of the Pain Relief Response
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52 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post treatmentThe 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
Outcome measures
| Measure |
Nerivio Device Treatment
n=32 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Functional Disability at 2 Hours Post-treatment
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19 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours post treatmentThe 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
Outcome measures
| Measure |
Nerivio Device Treatment
n=14 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Functional Disability at 24 Hours Post-treatment
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7 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours post treatmentThe proportion 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
| Measure |
Nerivio Device Treatment
n=45 Participants
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Sustained Pain Relief at 24 Hours Post-treatment
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33 Participants
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Adverse Events
Nerivio Device Treatment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nerivio Device Treatment
n=99 participants at risk
Treatment with active Nerivio device
Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
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|---|---|
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Nervous system disorders
Pain in the arm
|
1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
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Infections and infestations
Sinus infection
|
1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
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Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
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2.0%
2/99 • Number of events 2 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
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Infections and infestations
Ear infection
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1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
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Infections and infestations
viral infectioniral infection
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1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Infections and infestations
Tooth infection
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1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
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Nervous system disorders
Leg pain
|
1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
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Skin and subcutaneous tissue disorders
Poison ivy rash
|
1.0%
1/99 • Number of events 1 • Up to 12 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 the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
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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