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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089761
Recruitment Status : Active, not recruiting
First Posted : September 13, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Theranica

Brief Summary:

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

Show Show detailed description

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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
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Active Device
Treatment of acute migraine with an active form of Nerivio device
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.




Primary Outcome Measures :
  1. The safety of Nerivio device measured by incidence of adverse events [ Time Frame: 3 months ]
    The incidence of adverse events in general and by seriousness, severity and association to the device.

  2. Treatment tolerability of the Nerivio device by percent of subjects who fail to complete the treatment study [ Time Frame: 3 months ]
    The percent of subjects who fail to complete the study because of non-tolerated treatments


Secondary Outcome Measures :
  1. Pain relief at 2 hours post-treatment [ Time Frame: 2 hours ]
    The proportion of participants achieving pain relief, defined as improvement from severe or moderate pain to mild or none, or improvement from mild pain to none, at 2 hours post-treatment in the test treatment, with no use of rescue medication

  2. Pain-free at 2 hours post-treatment [ Time Frame: 2 hours ]
    The proportion of participants achieving pain freedom, defined as improvement from mild, moderate, or severe pain to none, at 2 hours post-treatment in the test treatment, with no use of rescue medication

  3. Disappearance of associated symptoms at 2 hours post-treatment [ Time Frame: 2 hours ]
    The proportion of participants reporting nausea at baseline and achieving absence of nausea, photophobia or phonophobia at 2 hours post-treatment in the test treatment


Other Outcome Measures:
  1. Sustained pain relief at 24 hours post-treatment [ Time Frame: 24 hours ]
    The proportion of participants achieving pain relief at 2 hours post-treatment in the test treatment, with no use of rescue medication and no relapse of headache pain within 24 hours



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
  2. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
  3. Participants with epilepsy.
  4. Medical use of cannabis or recreational use one month prior to enrollment.
  5. Participants who have undergone nerve block (occipital or other) in the head or neck within the last 2 weeks
  6. Treatment with onabotulinum toxin A (Botox) to the head and/or neck for 3 months before enrollment and/or during the study
  7. Any history of anti-CGRP antibody treatment
  8. Current participation in any other clinical study that includes treatment
  9. Participants without basic cognitive and motor skills required for operating a smartphone.
  10. Pregnant or breastfeeding females
  11. Pure menstrual migraine
  12. Participants who received parenteral treatments for migraine within the previous 2 weeks.
  13. Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
  14. Participants who have previous experience with the device
  15. Participants with arm circumference below 7.9 inches (20 cm)

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Theranica
Investigators
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Principal Investigator: Andrew Hershey, MD Director, Headache Center Cincinnati Children's Hospital Medical Center
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Responsible Party: Theranica
ClinicalTrials.gov Identifier: NCT04089761    
Other Study ID Numbers: TCH004
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Theranica:
Migraine treatment, Adolescence
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases