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NCT05940870 · ClinicalTrials.gov registry record
A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.
A clinical trial, sponsored by Theranica.
- Completed
- Registry status
- 250
- Enrollment target
NCT05940870: Completed study, sponsored by Theranica.
NCT05940870 is a clinical trial that has completed, run by Theranica. The registered enrollment target is 250 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05940870 has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- 250 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DEVICE Nerivio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-07-03 |
| Est. Completion | 2024-08-01 |
What the finished NCT05940870 record still lists
NCT05940870 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Nerivio is the first listed.
NCT05940870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05940870 about?
NCT05940870 is a clinical study titled "A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.". 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 ...
What is the current status of trial NCT05940870?
This trial is currently completed. The enrollment target is 250 participants. The study started on 2023-07-03. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT05940870?
The interventions under investigation include: Nerivio (DEVICE).
Who is sponsoring clinical trial NCT05940870?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
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