N/A
N=1,629
Real-world Data Analysis of REN Treatment in Adolescence With Migraine
Migraine in Adolescence
Bottom Line
View on ClinicalTrials.gov: NCT05443659 ↗Enrolled (actual)
1,629
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Consistent Pain Relief at 2 Hours Post-treatment — 158 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nerivio (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Theranica
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Consistent Pain Relief at 2 Hours Post-treatment |
158 | — |
| SECONDARY Consistent Pain Freedom at 2 Hours Post-treatment |
76 | — |
| SECONDARY Consistent Usage of Migraine Abortive (Rescue) Medications |
1524; 439; 180; 222 | — |
| SECONDARY Consistent Functional Disability Relief at 2 Hours Post-treatment |
159 | — |
| SECONDARY Consistent Functional Disability Disappearance at 2 Hours Post-treatment |
155 | — |
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.
Eligibility Criteria
Inclusion Criteria
- - Age between 12-18 years
- - REN user across the United States who created Nerivio account on January 1st, 2021 or later.
- - Had at least two evaluable treatments with the Nerivio device
Exclusion Criteria
(1) - Treatments shorter than 20 minutes
Data sourced from ClinicalTrials.gov (NCT05443659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.