Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600388
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2020-10-19
Brief Title:
Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Retrospective Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 sponsors database will be contacted by email provided by the patient during the sign-up process in the Nerivio app required to use the device andor 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
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 sponsors database will be contacted by email provided by the patient during the sign-up process in the Nerivio app required to use the device andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None