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NCT06138756 · ClinicalTrials.gov registry record
Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)
A clinical trial, sponsored by Theranica.
- Completed
- Registry status
- 293
- Enrollment target
NCT06138756: Completed study, sponsored by Theranica.
NCT06138756 is a clinical trial that has completed, run by Theranica. The registered enrollment target is 293 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06138756 has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- 293 participants
- Enrollment target
Study Summary
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.
Primary Outcome
Incidence of device-related adverse events reported by subjects throughout the study period
Interventions
- DEVICE Nerivio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2024-06-01 |
What the finished NCT06138756 record still lists
NCT06138756 is an observational study that tracks outcomes without assigning an intervention. The registered 293 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.
NCT06138756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06138756 about?
NCT06138756 is a clinical study titled "Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)". Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or witho...
What is the current status of trial NCT06138756?
This trial is currently completed. The enrollment target is 293 participants. The study started on 2023-10-01. Estimated completion is 2024-06-01.
What interventions are being tested in trial NCT06138756?
The interventions under investigation include: Nerivio (DEVICE).
Who is sponsoring clinical trial NCT06138756?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
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