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Completed

NCT Number: NCT04600388

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 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.

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Key information

Conditions

Menstrual Migraine

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Vassar Ambulatory Surgical Center

Poughkeepsie, New York, 12601, United States

About this study

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.

Informed consent must be obtained from the participant before any protocol-related activities are performed. 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.

Users of Nerivio whose details are in the sponsor's database will be contacted by email (provided by the patient during the sign-up process in the Nerivio app required to use the device) and/or through an app notification and will be asked to complete a 5-minute online survey assessing satisfaction, effectiveness, and safety. Participants will sign an informed consent form which will appear as the first page of the survey using open-ended questions, multiple choice questions and Likert scales. Participants will be directed to provide honest opinions regarding the device use for menstrual migraine. No additional information will be collected, and no medical records will be used in this investigation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-55 years
  • Participants have used Nerivio at least 4 times
  • Participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported)
  • Participants have used Nerivio to treat menstrual migraine

Exclusion criteria

  • Non-menstruating women

Treatment and study plan

Nerivio

Device

Nerivio Remote Electrical Neuromodulation (REN) device

Primary outcomes

  1. Efficacy of Nerivio during menstrual migraines

    Time frame: 3 months

    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)

  2. Satisfection of using Nerivio during menstrual migraines

    Time frame: 3 months

    Satisfection of using Nerivio during menstrual migraines rated on a 5-point Likert scale )1 - Not at all satisfied, 2 - Slightly dissatisfied, 3 - Neutral, 4 - Slightly satisfied, 5 -Extremely satisfied)

Secondary outcomes

  1. Mean headache relief

    Time frame: 3 months

    Mean percentage of menstrual migraine attacks in which relief was achieved

  2. Medication consumption

    Time frame: 3 months

    Percentage of menstrual migraine attacks in which acute medication was avoided following using the Nerivio

  3. Reduction of menstrual cramps

    Time frame: 3 months

    Percentage of patients reports reduction in menstrual cramps following using of Nerivio

Sponsors and collaborators

Lead sponsor

Theranica

Industry

Registry information

Official study title

Retrospective, Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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