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NCT04194008 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine
A NA study, sponsored by Theranica.
- Completed
- Registry status
- NA
- Development phase
- 126
- Enrollment target
NCT04194008: Completed NA study, sponsored by Theranica.
NCT04194008 is a NA study that has completed, run by Theranica. The registered enrollment target is 126 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04194008, a NA study, has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
Study Summary
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases: Phase I - Run-in: Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report . Phase II - Treatment: A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment. Phase III - Follow-up: An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.
Primary Outcome
The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be 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 | 126 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2020-08-30 |
| Phase | NA |
What the finished NCT04194008 record still lists
NCT04194008 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Nerivio is the first listed.
NCT04194008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04194008 about?
NCT04194008 is a clinical study titled "Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine". A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases: Phase I - Run-in: Eligible participants will be trained to use a smartphone migraine diary application. Durin...
What is the current status of trial NCT04194008?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2019-11-18. Estimated completion is 2020-08-30.
What interventions are being tested in trial NCT04194008?
The interventions under investigation include: Nerivio (DEVICE).
Who is sponsoring clinical trial NCT04194008?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04194008's enrollment target sits among peer trials
126 749th of 2000 higher than 1,248 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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