Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine
Public ClinicalTrials.gov record NCT04194008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open Label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of Nerivio, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases: Phase I - Run-in: Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report . Phase II - Treatment: A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment. Phase III - Follow-up: An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.
Study identification
- NCT ID
- NCT04194008
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 126 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2019 (Actual)
- Primary completion
- May 22, 2020 (Actual)
- Completion
- Aug 30, 2020 (Actual)
- Last update posted
- Feb 2, 2021
2019 – 2020
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Newport Beach Clinical Research Associates, Inc. | Newport Beach | California | 92663 | — |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | — |
| Hartford Healthcare Center | Hartford | Connecticut | 06102 | — |
| Headache Neurology Research Institute | Ridgeland | Mississippi | 39157 | — |
| StudyMetrix Research, LLC | City of Saint Peters | Missouri | 63303 | — |
| ClinVest | Springfield | Missouri | 65810 | — |
| Mercy Hospital | St Louis | Missouri | 63141 | — |
| Island Neurological | Plainview | New York | 11803 | — |
| Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | 15220 | — |
| Nashville neuroscience | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04194008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04194008 live on ClinicalTrials.gov.