Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents
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ClinicalTrials.gov Identifier: NCT04089761 |
Recruitment Status :
Terminated
(Due to the outbreak of the COVID-19 pandemic in the USA on March 2020, all study sites stopped enrolling patients to the study)
First Posted : September 13, 2019
Results First Posted : February 25, 2021
Last Update Posted : February 25, 2021
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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.
This is a prospective, single arm, open label, multicenter trial of the safety and efficacy of Nerivio™ for the acute treatment of migraine in adolescents
The study will be conducted in three phases:
Phase I - Run-in:
Phase II - Treatment phase:
Phase III (optional) - Free-use
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Migraine | Device: Nerivio | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | single arm, open-label, multicenter study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Arm, Open Label, Multicenter Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents |
Actual Study Start Date : | October 1, 2019 |
Actual Primary Completion Date : | May 10, 2020 |
Actual Study Completion Date : | May 24, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Active Device
Treatment of acute migraine with an active form of Nerivio device
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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 [ Time Frame: 12 weeks ]Number of Participants with Device-Related Adverse Events
- Pain Relief at 2 Hours Post Treatment [ Time Frame: 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)
- Pain-free at 2 Hours Post Treatment [ Time Frame: 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)
- Disappearance of Nausea at 2 Hours Post-treatment [ Time Frame: 2 hours post treatment ]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
- Disappearance of Photophobia at 2 Hours Post Treatment [ Time Frame: 2 hors post treatment ]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
- Disappearance of Phonophobia at 2 Hours Post Treatment [ Time Frame: 2 hours post treatment ]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
- Sustained Pain Relief at 24 Hours Post Treatment [ Time Frame: 24 hours post treatment ]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
- Sustained Pain Free at 24 Hours Post Treatment [ Time Frame: 24 hours post treatment ]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
- Functional Disability at 2 Hours Post Treatment [ Time Frame: 2 hours post treatment ]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
- Functional Disability at 24 Hours Post Treatment [ Time Frame: 24 hours post treatment ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Participants age 12-17 years old at the time of informed consent, inclusive. 2. Participants have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura 3. History of at least 3 migraine attacks per month for each of the 2 months preceding study enrolment 4. Typical headache duration of at least 3 hours (when untreated or unsuccessfully treatment) 5. Stable migraine preventive medications during the 2 months prior to enrollment (no change in usage or dosage).
6. Participants have personal access to a smartphone (24/7) 7. Participants must be able and willing to comply with the protocol 8. Parents/Guardians must be able and willing to provide written informed consent 9. Participants must be able and willing to provide informed assent
Exclusion Criteria:
- Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with epilepsy.
- Medical use of cannabis or recreational use one month prior to enrollment.
- Participants who have undergone nerve block (occipital or other) in the head or neck within the last 2 weeks
- Treatment with onabotulinum toxin A (Botox) to the head and/or neck for 3 months before enrollment and/or during the study
- Any history of anti-CGRP antibody treatment
- Current participation in any other clinical study that includes treatment
- Participants without basic cognitive and motor skills required for operating a smartphone.
- Pregnant or breastfeeding females
- Pure menstrual migraine
- Participants who received parenteral treatments for migraine within the previous 2 weeks.
- Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
- Participants who have previous experience with the device
- Participants with arm circumference below 7.9 inches (20 cm)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089761
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Clinical Trials Solutions | |
Hialeah, Florida, United States, 33012 | |
Nicklaus children hospital | |
Miami, Florida, United States, 33155 | |
United States, Georgia | |
PANDA neurology | |
Atlanta, Georgia, United States, 30328 | |
United States, Louisiana | |
Children Hospital New Orleans | |
New Orleans, Louisiana, United States, 70118 | |
United States, Missouri | |
Children Mercy Kansas City | |
Kansas City, Missouri, United States, 64108 | |
United States, New York | |
DENT neurology clinic | |
Amherst, New York, United States, 14226980 | |
NYU Langone-Health | |
New York, New York, United States, 10017 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia (CHOP) | |
Philadelphia, Pennsylvania, United States, 19178 | |
United States, Texas | |
Mercury Clinical Research | |
Houston, Texas, United States, 77036 | |
Texas Children's Hospital, Baylor College of Medicine | |
Houston, Texas, United States, 77094 |
Principal Investigator: | Andrew Hershey, MD | Director, Headache Center Cincinnati Children's Hospital Medical Center |
Documents provided by Theranica:
Responsible Party: | Theranica |
ClinicalTrials.gov Identifier: | NCT04089761 |
Other Study ID Numbers: |
TCH004 |
First Posted: | September 13, 2019 Key Record Dates |
Results First Posted: | February 25, 2021 |
Last Update Posted: | February 25, 2021 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Migraine treatment, Adolescence |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |