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NCT03361423 · ClinicalTrials.gov registry record · NA
Evaluation of a Novel Device for Treatment of Migraine Headache
A NA study, sponsored by Theranica.
- Completed
- Registry status
- NA
- Development phase
- 296
- Enrollment target
NCT03361423: Completed NA study, sponsored by Theranica.
NCT03361423 is a NA study that has completed, run by Theranica. The registered enrollment target is 296 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03361423, a NA study, has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- NA
- Development phase
- 296 participants
- Enrollment target
Study Summary
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere. This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications. The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura. The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts. The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
Primary Outcome
The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
Interventions
- DEVICE Nerivio Migra-1 active device
- DEVICE Nerivio Migra-1 Sham device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2017-12-17 |
| Est. Completion | 2018-12-25 |
| Phase | NA |
What the finished NCT03361423 record still lists
NCT03361423 is an interventional study that assigns participants to a tested intervention. The registered 296 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Nerivio Migra-1 active device is the first listed.
NCT03361423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03361423 about?
NCT03361423 is a clinical study titled "Evaluation of a Novel Device for Treatment of Migraine Headache". Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches includin...
What is the current status of trial NCT03361423?
This trial is currently completed. It is a NA study. The enrollment target is 296 participants. The study started on 2017-12-17. Estimated completion is 2018-12-25.
What interventions are being tested in trial NCT03361423?
The interventions under investigation include: Nerivio Migra-1 active device (DEVICE), Nerivio Migra-1 Sham device (DEVICE).
Who is sponsoring clinical trial NCT03361423?
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 NCT03361423's enrollment target sits among peer trials
296 373rd of 2000 higher than 1,628 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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