Menstrual MigraineNCT04600388
Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
An observational study of Menstrual Migraine, run by Theranica at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 10 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Menstruating women aged 18-55 years who have used Nerivio at least 4 times and have menstrual migraine.
Who may be able to join
- 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
Who cannot join
- 1. Non-menstruating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Vassar Ambulatory Surgical Center
Poughkeepsie, New York, 12601
About this study
Official title: Retrospective, Observational Survey Study to Assess the 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.
Read the 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.
- Conditions
- Menstrual Migraine
- Being tested
- Nerivio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
Nerivio Remote Electrical Neuromodulation (REN) device
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
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)
Measured: 3 months
Secondary outcomes (3)
Mean headache relief
Mean percentage of menstrual migraine attacks in which relief was achieved
Measured: 3 months
Medication consumption
Percentage of menstrual migraine attacks in which acute medication was avoided following using the Nerivio
Measured: 3 months
Reduction of menstrual cramps
Percentage of patients reports reduction in menstrual cramps following using of Nerivio
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start9 Sep 2020
- Primary completion1 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hida Nierenburg, MD, Principal investigator, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600388
- Sponsor's protocol ID
- TCH009
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plean for IPD
Publications
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.
PubMed 34138449
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
- ClinicalTrials.gov ID
- NCT04600388
- Acronym / sponsor ID
- TCH009
- Conditions
- Menstrual Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Menstruating women aged 18-55 years who have used Nerivio at least 4 times and have menstrual migraine.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Non-menstruating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NerivioNerivio Remote Electrical Neuromodulation (REN) device | Device | – |
Primary outcome
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)
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)
3 secondary outcomes
Mean headache relief
Time frame: 3 months
Medication consumption
Time frame: 3 months
Reduction of menstrual cramps
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 34138449Nierenburg 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.
- Individual participant dataSharing planned: No. No plean for IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hida Nierenburg, MD principal investigator
Nuvance Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Migraine, run by Theranica at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Nerivio during menstrual migraines (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.