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NCT05443659 · ClinicalTrials.gov registry record
Real-world Data Analysis of REN Treatment in Adolescence With Migraine
A clinical trial, sponsored by Theranica.
- Completed
- Registry status
- 1,629
- Enrollment target
NCT05443659: Completed study, sponsored by Theranica.
NCT05443659 is a clinical trial that has completed, run by Theranica. The registered enrollment target is 1,629 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05443659 has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- 1,629 participants
- Enrollment target
Study Summary
This is a Post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, Israel) in adolescents with migraine. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other medications will be performed.
Primary Outcome
The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)
Interventions
- DEVICE Nerivio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,629 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2022-08-24 |
What the finished NCT05443659 record still lists
NCT05443659 is an observational study that tracks outcomes without assigning an intervention. Its 1,629 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Nerivio is the first listed.
NCT05443659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05443659 about?
NCT05443659 is a clinical study titled "Real-world Data Analysis of REN Treatment in Adolescence With Migraine". This is a Post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, Israel) in adolescents with migraine. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other me...
What is the current status of trial NCT05443659?
This trial is currently completed. The enrollment target is 1,629 participants. The study started on 2021-01-01. Estimated completion is 2022-08-24.
What interventions are being tested in trial NCT05443659?
The interventions under investigation include: Nerivio (DEVICE).
Who is sponsoring clinical trial NCT05443659?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
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