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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 is a NA study that has completed, run by Theranica. The registered enrollment target is 126 participants.
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.
Interventions
- DEVICE Nerivio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2020-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04194008
The ClinicalTrials.gov registry entry for NCT04194008 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theranica, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nerivio is the first listed.
NCT04194008 reports 0 study locations.
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.
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