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

• Sponsor: Theranica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04600388
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 59.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Migraine	Device: Nerivio

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 121 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Retrospective, Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
• Actual Study Start Date: Sep 9, 2020
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Nov 10, 2020

Outcome Measures

Primary Outcome Measures

1. Efficacy of Nerivio during menstrual migraines [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 [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 Outcome Measures

1. Mean headache relief [3 months]

   Mean percentage of menstrual migraine attacks in which relief was achieved

2. Medication consumption [3 months]

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

3. Reduction of menstrual cramps [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vassar Ambulatory Surgical Center	Poughkeepsie	New York	United States	12601

Sponsors and Collaborators

• Theranica

Investigators

• Principal Investigator: Hida Nierenburg, MD, Nuvance Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theranica
• ClinicalTrials.gov Identifier: NCT04600388
• Other Study ID Numbers: TCH009
• First Posted: Oct 23, 2020
• Last Update Posted: Dec 4, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Migraine Disorders; Premenstrual Syndrome

Study Results

No Results Posted as of Dec 4, 2020