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NCT05760638 · ClinicalTrials.gov registry record
Real-World Evidence (RWE) Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation (REN)
A clinical trial, sponsored by Theranica.
- Completed
- Registry status
- 409
- Enrollment target
NCT05760638: Completed study, sponsored by Theranica.
NCT05760638 is a clinical trial that has completed, run by Theranica. The registered enrollment target is 409 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05760638 has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- 409 participants
- Enrollment target
Study Summary
This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients. Safety will be assessed by the number and type of adverse events. Utilization will be measured by the number of monthly treatments. Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments.
Primary Outcome
Incidence of device-related adverse events reported by subjects
Interventions
- DEVICE Nerivio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2023-04-02 |
What the finished NCT05760638 record still lists
NCT05760638 is an observational study that tracks outcomes without assigning an intervention. The registered 409 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.
NCT05760638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05760638 about?
NCT05760638 is a clinical study titled "Real-World Evidence (RWE) Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation (REN)". This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients. Safety will be assessed by the number and type of adverse events. Utilization will be measured by the number of monthly treatments....
What is the current status of trial NCT05760638?
This trial is currently completed. The enrollment target is 409 participants. The study started on 2023-03-01. Estimated completion is 2023-04-02.
What interventions are being tested in trial NCT05760638?
The interventions under investigation include: Nerivio (DEVICE).
Who is sponsoring clinical trial NCT05760638?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
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