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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: Completed NA study, sponsored by Theranica.
NCT04828707 is a NA study that has completed, run by Theranica. The registered enrollment target is 335 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The mean reduction in the number of migraine days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A migraine day is defined as a calendar day with a headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.
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 |
What the finished NCT04828707 record still lists
NCT04828707 is an interventional study that assigns participants to a tested intervention. The registered 335 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Nerivio active device is the first listed.
NCT04828707 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04828707's enrollment target sits among peer trials
335 305th of 2000 higher than 1,696 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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