Theranica conducts a clinical trial of Nerivio for the acute treatment of menstrual migraine

Photo by Anthony Tran

Biomedical technology company is recruiting patients for retrospective, observational survey study to assess the efficacy and safety of Nerivio for the acute treatment of menstrual migraine.

It is 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 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.

This study aims to evaluate the safety and efficacy of Nerivio for the acute treatment of menstrual migraine (pure menstrual migraine or menstrually-related migraine).

Up to 500 US-based adults aged 18-55 years old who have been prescribed the Nerivio device and have used it at least 4 times between October 2019 and December 2020.

The first participant was enrolled in a clinical study on September 9, 2020.

The planned outcome measures that are the most important for evaluating the effect of the treatment:

  1. Efficacy of Nerivio during menstrual migraines. Efficacy of Nerivio for headache relief during menstrual migraines rated on a 5-point Likert scale.
  2. Satisfection of using Nerivio during menstrual migraines. Satisfection of using Nerivio during menstrual migraines rated on a 5-point Likert scale.

The location of the clinical trials: Vassar Ambulatory Surgical Center, Poughkeepsie, New York, United States, 12601.

For more details please check the study details here: https://ichgcp.net/clinical-trials-registry/NCT04600388

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