Nerivio Efficacy by Time of Treatment Onset

NCT06976723 | Completed Phase 4 FDA Device

• 1 other identifier: RWE-010
• Study Type: interventional
• Target: 55,261
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Post-marketing study investigating the impact of treatment time onset with Nerivio on the efficacy of Remote Electrical Neuromodulation (REN) for the acute treatment of migraine. Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments, based on the treatment start time from the beginning of the migraine attack.

Conditions

Migraine; Acute Treatment of Migraine

Keywords

Nerivio; Remote Electrical Neuromodulation

Outcome Measures

Primary Outcomes (2)

• Pain Relief

  Proportion of treatments in which there was a reduction in headache intensity from moderate or severe headache at baseline to mild or no pain 2 hours post-treatment.

  2 hours post treatment

• Pain Freedom:

  Proportion of treatments in which there was a reduction in headache intensity from mild or moderate or severe headache at baseline to no headache 2 hours post-treatment.

  2 hours post treatment

Secondary Outcomes (4)

• Functional Disability Relief

  2 hours post treatment

• Functional Disability Freedom

  2 hours post treatment

• Freedom from each migraine-associated symptom (Photophobia, Phonophobia, Nausea/Vomiting)

  2 hours post treatment

• Consistent efficacy

  2 hours post treatment

Study Arms (2)

Early treatment

ACTIVE COMPARATOR

Nerivio treatment was administered within 60 minutes of migraine onset

Device: Nerivio

Late treatment

ACTIVE COMPARATOR

Nerivio treatment was administered more than 60 minutes after migraine onset

Device: Nerivio

Interventions

Nerivio DEVICE

Remote electrical neuromodulation (REN) device for the acute treatment of migraines. 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

Early treatment; Late treatment

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Users who had reported treatment onset time in at least one treatment through the REN companion smartphone app

You may not qualify if:

• Treatments that included medications for acute treatment of migraine

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Theranica Bio-Electronics Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alit Stark-Inbar, PhD

  Theranica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1. \- Nerivio treatments within 60 minutes from migraine attack onset 2. \- Nerivio treatments over 60 minutes from migraine attack onset

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 16, 2025
• Study Start: May 7, 2025
• Primary Completion: June 10, 2025
• Study Completion: June 15, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-05

Locations

US (1)