A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.

NCT05940870 | Completed FDA Device

• 1 other identifier: TCH015
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Nerivio is a remote electrical neuromodulation (REN) device that is FDA-cleared for migraine prevention (as well as for acute treatment of migraine), in individuals 12 and older. The study is a post-marketing, observational, prospective, real-world evidence study assessing the safety, efficacy, and health economics outcomes of Nerivio for migraine prevention in a real-world environment. The study population is naïve Nerivio users, aged 12 and up, who were prescribed Nerivio by their healthcare provider for either prevention treatment (for use every other day) or dual-use treatment (for use every other day and upon the onset of a migraine). The study period per participant is six months. During this period, participants will be requested to use Nerivio according to the instructions of their healthcare provider and to fill out a short daily questionnaire in the Nerivio application

Conditions

Migraine

Keywords

migraine prevention; Remote electrical neuromodulation

Outcome Measures

Primary Outcomes (2)

• Change in monthly mean number of migraine days from baseline to weeks 9-12 of the study.

  Change in number of monthly migraine days depicting the change in the number of migraine days from baseline, as reported by the patient, to weeks 9-12 of the study. Migraine Day: a calendar day with a headache that is either accompanied by at least one of the following symptoms: 1. Photophobia/phonophobia 2. nausea (with or without vomiting), OR is treated with a migraine-specific acute medication.

  12 weeks

• Rate of Adverse Events (Safety and Tolerability)

  Numer of AE, SAE and Device-related Adverse Events

  24 weeks

Secondary Outcomes (3)

• Change in the monthly number of monthly headache days from weeks 1-4 to weeks 9-12.

  12 weeks

• Change in monthly mean number of migraine days from baseline to weeks 21-24

  24 weeks

• Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 9-12.

  12 weeks

Other Outcomes (10)

• Change in the number of monthly headache days from weeks 1-4 to weeks 21-24.

  24 weeks

• Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 21-24.

  24 weeks

• Change in monthly mean number of migraine days from baseline to weeks 21-24 of the study.

  24 weeks

Study Arms (1)

Nerivio treatment for migraine prevention

Patients with migraine who recieved the Nerivio device for migraine prevention therapy

Device: Nerivio

Interventions

Nerivio DEVICE

Patients with migraine who received the Nerivio device for migraine prevention therapy

Nerivio treatment for migraine prevention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Migraine patients aged 12 or above who were prescribed Nerivio for prevention or dual use treatment of migraine

You may qualify if:

• Age 12 years old or above.
• Were prescribed with Nerivio for prevention (or for dual use) after April 1st.
• Have performed up to 3 preventive treatment sessions and have never used Nerivio before that.
• Have had at least 4 migraine attacks per month (according to self-report).
• Stable on the same migraine prevention treatment for the last two months prior to enrollment.
• Signed an electronic Informed Consent Form and agreed to fill the Daily Diary in the Nerivio mobile app on a daily basis.

You may not qualify if:

• None

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Theranica Inc USA

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

  Theranica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 11, 2023
• Study Start: July 3, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2023-06

Locations

US (1)