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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 is a NA study that has completed, run by Theranica. The registered enrollment target is 296 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03361423
The ClinicalTrials.gov registry entry for NCT03361423 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 296 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 2 interventions - of which Nerivio Migra-1 active device is the first listed.
NCT03361423 reports 0 study locations.
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.
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