Clinical trial NCT04600388: Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
Official title: Retrospective, Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Migraine
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Menstruating women aged 18-55 years who have used Nerivio at least 4 times and have menstrual migraine.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of Nerivio during menstrual migraines
timeFrame: 3 months
measure: Satisfection of using Nerivio during menstrual migraines
timeFrame: 3 months
Secondary outcomes:
measure: Mean headache relief
timeFrame: 3 months
measure: Medication consumption
timeFrame: 3 months
measure: Reduction of menstrual cramps
timeFrame: 3 months
Other outcomes:
Locations:
city: Poughkeepsie
country: United States
facility: Vassar Ambulatory Surgical Center
state: New York
Study officials:
affiliation: Nuvance Health
name: Hida Nierenburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nierenburg H, Rabany L, Lin T, Sharon R, Harris D, Ironi A, Wright P, Chuang L. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. 2021 Dec;10(2):1245-1253. doi: 10.1007/s40122-021-00276-7. Epub 2021 Jun 17.