Clinical trialNCT04089761TerminatedInterventional

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

SponsorTheranicaEnrollment60Acute Migraine

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrew Hershey, MD
Director, Headache Center Cincinnati Children's Hospital Medical Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Oct 2019
Primary completion: 10 May 2020
Completion: 24 May 2020
Last update posted: 25 Feb 2021
Registered enrollment: 60
Registry id: NCT04089761

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.