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

Stopped early · Not applicable

Conditions studied: Acute Migraine

In brief

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

Key facts

Study ID

NCT04089761

Run by

Theranica

People needed

60

Starts

2019-10-01

Expected to finish

2020-05-24

Last updated by the study team

2021-02-25

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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

You may not qualify if…

• 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)

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Clinical Trials Solutions — Hialeah, Florida, United States
• Nicklaus children hospital — Miami, Florida, United States
• PANDA neurology — Atlanta, Georgia, United States
• Children Hospital New Orleans — New Orleans, Louisiana, United States
• Children Mercy Kansas City — Kansas City, Missouri, United States
• DENT neurology clinic — Amherst, New York, United States
• NYU Langone-Health — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States
• Mercury Clinical Research — Houston, Texas, United States
• Texas Children's Hospital, Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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