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NCT04828707 · ClinicalTrials.gov registry record · NA
Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
A NA study, sponsored by Theranica.
- Completed
- Registry status
- NA
- Development phase
- 335
- Enrollment target
NCT04828707 is a NA study that has completed, run by Theranica. The registered enrollment target is 335 participants.
The verdict
NCT04828707, a NA study, has completed, sponsored by Theranica.
- COMPLETED
- Registry status
- NA
- Development phase
- 335 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. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention. The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases. The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase. Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase. The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).
Interventions
- DEVICE Nerivio active device
- DEVICE Nerivio sham device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2022-10-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04828707
The ClinicalTrials.gov registry entry for NCT04828707 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 335 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 active device is the first listed.
NCT04828707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04828707 about?
NCT04828707 is a clinical study titled "Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention". 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. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention. The study is a ...
What is the current status of trial NCT04828707?
This trial is currently completed. It is a NA study. The enrollment target is 335 participants. The study started on 2021-04-13. Estimated completion is 2022-10-10.
What interventions are being tested in trial NCT04828707?
The interventions under investigation include: Nerivio active device (DEVICE), Nerivio sham device (DEVICE).
Who is sponsoring clinical trial NCT04828707?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
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