Nerivio for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and tolerability of the Nerivio device when used frequently to treat migraines. Specifically, it examines using Nerivio more often than standard guidelines, such as treating four times in a day or using it almost daily for a month. It suits current Nerivio users who already use it frequently to manage their migraines. The researchers seek to understand if increased usage affects safety or effectiveness. As a Phase 4 trial, this research helps determine how the FDA-approved and effective Nerivio device benefits more patients.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What is the safety track record for Nerivio?
Research shows that Nerivio, a wearable device for treating migraines, is safe and generally well-tolerated. Studies have found that side effects related to the device are rare, and most users do not experience major side effects. The FDA has approved it, indicating it has passed safety checks for treating migraines.
In earlier studies, participants used Nerivio regularly and tolerated it well. This ongoing study tests whether more frequent use remains safe. Overall, existing evidence suggests that Nerivio is a safe option for treating migraines.12345Why are researchers enthusiastic about this study treatment?
Nerivio is unique because it offers a non-drug alternative for migraine relief through the use of a wearable device that employs remote electrical neuromodulation. This approach is different from standard migraine treatments, which typically include medications like triptans or NSAIDs. Researchers are excited about Nerivio because it provides a drug-free option that can be used frequently without the risk of medication overuse, potentially reducing side effects and increasing convenience for users who need multiple treatments within short periods.
What is the effectiveness track record for Nerivio in treating migraines?
Research has shown that Nerivio effectively treats migraines, providing long-lasting relief without medication or dose escalation. In one study, 74.1% of patients experienced pain relief in at least half of their treatments over a year. Another study found that using Nerivio every other day significantly reduced migraine severity compared to a placebo. Overall, it is a safe and well-tolerated option for managing migraines. Participants in this trial will use Nerivio under specific treatment patterns to further evaluate its effectiveness.26789
Who Is on the Research Team?
Alit Stark-Inbar, PhD
Principal Investigator
Theranica
Are You a Good Fit for This Trial?
This trial is for individuals who frequently experience migraines and have used Nerivio, a Remote Electrical Neuromodulation device. Participants must have treated themselves with Nerivio at least four times in one day or at least once on 25 out of 28 consecutive days.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the REN device for migraine treatment at frequencies exceeding the labeled indication, including multiple treatments per day or daily use.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nerivio
Trial Overview
The study is examining the safety of using the Nerivio device more often than what's currently recommended. It aims to understand if there are any additional risks when patients use this migraine treatment very frequently.
How Is the Trial Designed?
1
Treatment groups
Active Control
Nerivio users who treatedfrequantly with Nerivio under the following regiemes: 1. \- Multiple treatments per day: defined as administrating 4 or more full treatments on a single day. 2. \- Administrating at least one full treatment on 25 or more days within a 28-day period. For each patient, all possible 28-day windows containing at least 25 treatment days were identified.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Theranica
Lead Sponsor
Citations
Nerivio USA
The findings of the study show that Nerivio is effective for the acute treatment of migraine in people with chronic migraine.
One-Year Consistent Safety, Utilization, and Efficacy ...
REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option.
3.
nerivio.com
nerivio.com/clinical-trials/real-world-evidence-rwe-data-analysis-of-1-year-consecutive-use-of-nerivio-nct05760638One-Year Consistent Safety, Utilization, and Efficacy ...
One-year average annual consistent efficacy in at least 50% of all treatments per patient was achieved by 74.1% (180/243) of patients for pain relief and by ...
4.
neurologylive.com
neurologylive.com/view/nerivio-ren-wearable-delivers-consistent-drug-free-relief-over-three-years-study-showsNerivio REN Wearable Delivers Consistent Drug-Free ...
A new study confirms the Nerivio REN wearable provides long-term, drug-free migraine relief without dosage increases, ensuring consistent ...
5.
nerivio.com
nerivio.com/clinical-trials/safety-and-efficacy-of-nerivio-for-the-preventive-treatment-of-migraineA double-blind, randomized, placebo-controlled clinical trial
The findings of the study show that treatment with Nerivio every other day is significantly more effective than sham. There was a reduction of 3.97±0.41 Vs. 1. ...
Nerivio® REN Wearable: Indication & Safety Information
Discover the indications and safety information for Nerivio® REN Wearable, an FDA-cleared, non-invasive device for migraine treatment and prevention.
DEN180059.pdf - accessdata.fda.gov
The Nerivio Migra is indicated for acute treatment of migraine with or without aura in patients. 18 years of age or older who do not have chronic migraine. It ...
8.
nerivio.com
nerivio.com/clinical-trials/an-open-label-single-arm-multicenter-study-assessing-the-efficacy-and-safety-of-nerivioan open-label study
The results of the study show that Nerivio is safe to use and is well-tolerated. The incidences of device-related adverse events were low with no device- ...
Assessment of Safety and Efficacy of Nerivio for ...
Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention.
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