Nerivio Long-term Usage in Patients With Migraine

Theranica

Status: Completed

Conditions: Acute Treatment of Migraine; Migraine

Treatments: Device: Nerivio

Study type: Observational

Funder types: Industry

Identifiers

NCT06738056

RWE-008

Details and patient eligibility

About

This is a post-marketing real-world evidence study investigates long-term treatment with the Remote Electrical Neuromodulation (REN) wearable Nerivio device over 3 consecutive years in patients with migraine.

Full description

The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 8 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device.

As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraine and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.

This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:

Primary endpoint:

1. Lack of Tachyphylaxis - No clinically meaningful change in treatment intensity between years.

Secondary endpoints:

1. Consistent effectiveness - Stable pain relief, freedom from pain, functional disability relief, return to normal function (no disability), and freedom from associated symptoms at 2 hours post-treatment relative to baseline in at least 50% of the treatments between years.
2. Utilization - Stable average number of monthly Nerivio treatments per year between years.
3. Safety and tolerability- Number and severity of device related adverse events.

Together, these four objectives provide a comprehensive evaluation of the long-term tolerability, safety, and efficacy of the Nerivio device using a real-world dataset.

Enrollment: 244 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. • Users who began treating with the REN wearable device between December 2019 and September 2021.
2. • Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
3. • Users with at least one treatment recorded in each of the counted months.

Exclusion criteria

None

Trial design

244 participants in 1 patient group

Nerivio users

Description:

Patients with migraine who were prescribed the REN wearable device for the treatment of their migraine and began treating between December 2019 and September 2021

Treatment:

Device: Nerivio