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Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention

NCT04828707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2023-03-15

Study results available
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Summary

Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention.

The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases.

The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.

Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase.

The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).

Conditions

Interventions

DEVICE

Nerivio active device

Nerivio neurostimulator of conditional pain modulation (CPM)

DEVICE

Nerivio sham device

Nerivio neurostimulator with an electrical output not intended for neurostimulation

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Robert Cowan, MD · Stanford Health Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2022-08-31
Completion
2022-10-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828707 on ClinicalTrials.gov