NCT05940870Completed
A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.
A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 28 Jun 2023
- Start date
- Jul 2023
- Primary completion date
- Jun 2024
- Lead sponsor
- Theranica
- Diseases
- Migraine
- NCT number
- NCT05940870
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From Jul 2023 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Theranica Inc USA Coordinator of this site? Confirm its status | Bridgewater | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.