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NCT04600388 · ClinicalTrials.gov registry record

Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

A clinical trial, sponsored by Theranica.

Completed
Registry status
121
Enrollment target

NCT04600388: Completed study, sponsored by Theranica.

NCT04600388 is a clinical trial that has completed, run by Theranica. The registered enrollment target is 121 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04600388 has completed, sponsored by Theranica.

COMPLETED
Registry status
121 participants
Enrollment target

Study Summary

Post-marketing, retrospective, observational survey study. Users (menstruating women only) of Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. Eligible users will sign an informed consent form (the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page) and complete a survey asking about their satisfaction with Nerivio and the effectiveness and safety of the device for acute treatment of menstrual migraine. During the survey, participants will be screened to verify that they have menstrual migraine (self-reported) and have used Nerivio to treat menstrual migraines.

Primary Outcome

Efficacy of Nerivio for headache relief during menstrual migraines rated on a 5-point Likert scale (1 - Not at all effective, 2 - Slightly effective, 3 - Moderately effective, 4 - Very effective, 5- Extremely effective)

Interventions

  • DEVICE Nerivio

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2020-09-09
Est. Completion 2020-11-10
Theranica

22 total trials

What the finished NCT04600388 record still lists

NCT04600388 is an observational study that tracks outcomes without assigning an intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Nerivio is the first listed.

NCT04600388 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04600388 about?

NCT04600388 is a clinical study titled "Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine". Post-marketing, retrospective, observational survey study. Users (menstruating women only) of Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous ...

What is the current status of trial NCT04600388?

This trial is currently completed. The enrollment target is 121 participants. The study started on 2020-09-09. Estimated completion is 2020-11-10.

What interventions are being tested in trial NCT04600388?

The interventions under investigation include: Nerivio (DEVICE).

Who is sponsoring clinical trial NCT04600388?

This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04600388, the US trial registry maintained by the National Library of Medicine. NCT04600388 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.