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

Menstrual Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600388
• Other study ID #: TCH009
• Status: Completed
• Start date: September 9, 2020
• Est. completion date: November 10, 2020

Study information

• Verified date: October 2020
• Source: Theranica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 10, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Women aged 18-55 years

2. Participants have used Nerivio at least 4 times

3. Participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported)

4. Participants have used Nerivio to treat menstrual migraine

Exclusion Criteria:

1. Non-menstruating women

Related Conditions & MeSH terms

• Menstrual Migraine
• Migraine Disorders
• Premenstrual Syndrome

Intervention

Device:
• Nerivio
Nerivio Remote Electrical Neuromodulation (REN) device

Locations

Country	Name	City	State
United States	Vassar Ambulatory Surgical Center	Poughkeepsie	New York

Sponsors (1)

Lead Sponsor	Collaborator
Theranica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Nerivio during menstrual migraines	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)	3 months
Primary	Satisfection of using Nerivio during menstrual migraines	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)	3 months
Secondary	Mean headache relief	Mean percentage of menstrual migraine attacks in which relief was achieved	3 months
Secondary	Medication consumption	Percentage of menstrual migraine attacks in which acute medication was avoided following using the Nerivio	3 months
Secondary	Reduction of menstrual cramps	Percentage of patients reports reduction in menstrual cramps following using of Nerivio	3 months