MigraineNCT05940870
A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.
An observational study of Migraine, run by Theranica at 1 site in United States.
Trial summary
Nerivio is a remote electrical neuromodulation (REN) device that is FDA-cleared for migraine prevention (as well as for acute treatment of migraine), in individuals 12 and older. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 1 Aug 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Migraine patients aged 12 or above who were prescribed Nerivio for prevention or dual use treatment of migraine
Who may be able to join
- Age 12 years old or above.
- Were prescribed with Nerivio for prevention (or for dual use) after April 1st.
- Have performed up to 3 preventive treatment sessions and have never used Nerivio before that.
- Have had at least 4 migraine attacks per month (according to self-report).
- Stable on the same migraine prevention treatment for the last two months prior to enrollment.
- Signed an electronic Informed Consent Form and agreed to fill the Daily Diary in the Nerivio mobile app on a daily basis.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.
Nerivio is a remote electrical neuromodulation (REN) device that is FDA-cleared for migraine prevention (as well as for acute treatment of migraine), in individuals 12 and older. The study is a post-marketing, observational, prospective, real-world evidence study assessing the safety, efficacy, and health economics outcomes of Nerivio for migraine prevention in a real-world environment. The study population is naïve Nerivio users, aged 12 and up, who were prescribed Nerivio by their healthcare provider for either prevention treatment (for use every other day) or dual-use treatment (for use every other day and upon the onset of a migraine). The study period per participant is six months. During this period, participants will be requested to use Nerivio according to the instructions of their healthcare provider and to fill out a short daily questionnaire in the Nerivio application
Read the detailed description
Nerivio is an FDA-approved remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura. Nerivio delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. The study will assess the safety and efficacy of Nerivio, used every other day for prevention and possibly whenever needed for acute treatment, as prescribed to participants by their own healthcare provider. The study will also assess certain health economics outcomes related to the treatment.
Patients aged 12 or above who were prescribed Nerivio for prevention or dual-use treatment of migraine after April 1st.
New Nerivio users will be sent an invitation message (via in-app notification and email), inviting them to fill out a Screening Eligibility Questionnaire. Those who meet the eligibility criteria will be offered to participate in the study. Candidate participants will then complete and sign an electronic Informed Consent Form (ICF). Immediately following this, participants will receive a Baseline Questionnaire with questions relating to the time period prior to using Nerivio.
The study duration for each participant is 24 weeks. During this time, participants will fill out the Daily Diary in the Nerivio App. In the middle of the study period (end of week 12), and at the end of the 24 weeks, participants will be asked to fill out follow-up questionnaires (Mid-study questionnaire \& Completion questionnaire) with questions on migraine and related symptoms, medication intake, health economics, and satisfaction with the treatment.
Participants who stop treatment will be sent a Completion questionnaire concerning the reason for their withdrawal.
- Conditions
- Migraine
- Being tested
- Nerivio
- Keywords
- migraine prevention, Remote electrical neuromodulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
Patients with migraine who received the Nerivio device for migraine prevention therapy
| Study group | Role | What they receive |
|---|---|---|
| Nerivio treatment for migraine prevention | Patients with migraine who recieved the Nerivio device for migraine prevention therapy Receives: Device: Nerivio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly mean number of migraine days from baseline to weeks 9-12 of the study.
Change in number of monthly migraine days depicting the change in the number of migraine days from baseline, as reported by the patient, to weeks 9-12 of the study.
Migraine Day: a calendar day with a headache that is either accompanied by at least one of the following symptoms: 1. Photophobia/phonophobia 2. nausea (with or without vomiting), OR is treated with a migraine-specific acute medication.
Measured: 12 weeks
Rate of Adverse Events (Safety and Tolerability)
Numer of AE, SAE and Device-related Adverse Events
Measured: 24 weeks
Secondary outcomes (3)
Change in the monthly number of monthly headache days from weeks 1-4 to weeks 9-12.
Change in number of monthly headache days depicting the change in the number of headache days from weeks 1-4 to weeks 9-12.
Headache Day: a calendar day with a headache of any severity.
Measured: 12 weeks
Change in monthly mean number of migraine days from baseline to weeks 21-24
Change in number of monthly migraine days depicting the change in the number of migraine days from baseline, as reported by the patient, to weeks 21-24 of the study.
Measured: 24 weeks
Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 9-12.
Change in number of monthly prescribed acute medication intake days depicting the change in the number of prescribed acute medication intake days from weeks 1-4 to that of weeks 9-12 of the study
Acute Medication Day: a calendar day on which the participant took at least one prescribed medication for acute treatment of migraine.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start3 Jul 2023
- Primary completion30 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alit Stark Inbar, Principal investigator, Theranica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940870
- Sponsor's protocol ID
- TCH015
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.
- ClinicalTrials.gov ID
- NCT05940870
- Acronym / sponsor ID
- TCH015
- Conditions
- Migraine
- Keywords
- migraine prevention, Remote electrical neuromodulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 11 Jul 2023 (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.
Nerivio is a remote electrical neuromodulation (REN) device that is FDA-cleared for migraine prevention (as well as for acute treatment of migraine), in individuals 12 and older. The study is a post-marketing, observational, prospective, real-world evidence study assessing the safety, efficacy, and health economics outcomes of Nerivio for migraine prevention in a real-world environment. The study population is naïve Nerivio users, aged 12 and up, who were prescribed Nerivio by their healthcare provider for either prevention treatment (for use every other day) or dual-use treatment (for use every other day and upon the onset of a migraine). The study period per participant is six months. During this period, participants will be requested to use Nerivio according to the instructions of their healthcare provider and to fill out a short daily questionnaire in the Nerivio application
Detailed description
Nerivio is an FDA-approved remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura. Nerivio delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. The study will assess the safety and efficacy of Nerivio, used every other day for prevention and possibly whenever needed for acute treatment, as prescribed to participants by their own healthcare provider. The study will also assess certain health economics outcomes related to the treatment.
Patients aged 12 or above who were prescribed Nerivio for prevention or dual-use treatment of migraine after April 1st.
New Nerivio users will be sent an invitation message (via in-app notification and email), inviting them to fill out a Screening Eligibility Questionnaire. Those who meet the eligibility criteria will be offered to participate in the study. Candidate participants will then complete and sign an electronic Informed Consent Form (ICF). Immediately following this, participants will receive a Baseline Questionnaire with questions relating to the time period prior to using Nerivio.
The study duration for each participant is 24 weeks. During this time, participants will fill out the Daily Diary in the Nerivio App. In the middle of the study period (end of week 12), and at the end of the 24 weeks, participants will be asked to fill out follow-up questionnaires (Mid-study questionnaire \& Completion questionnaire) with questions on migraine and related symptoms, medication intake, health economics, and satisfaction with the treatment.
Participants who stop treatment will be sent a Completion questionnaire concerning the reason for their withdrawal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerivio treatment for migraine prevention | – | Device: NerivioPatients with migraine who recieved the Nerivio device for migraine prevention therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Migraine patients aged 12 or above who were prescribed Nerivio for prevention or dual use treatment of migraine
Key inclusion criteria (6 listed)
- Age 12 years old or above.
- Were prescribed with Nerivio for prevention (or for dual use) after April 1st.
- Have performed up to 3 preventive treatment sessions and have never used Nerivio before that.
- Have had at least 4 migraine attacks per month (according to self-report).
- Stable on the same migraine prevention treatment for the last two months prior to enrollment.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| NerivioPatients with migraine who received the Nerivio device for migraine prevention therapy | Device | Nerivio treatment for migraine prevention |
Primary outcome
Change in monthly mean number of migraine days from baseline to weeks 9-12 of the study.
Time frame: 12 weeks
Change in number of monthly migraine days depicting the change in the number of migraine days from baseline, as reported by the patient, to weeks 9-12 of the study. Migraine Day: a calendar day with a headache that is either accompanied by at least one of the following symptoms: 1. Photophobia/phonophobia 2. nausea (with or without vomiting), OR is treated with a migraine-specific acute medication.
Rate of Adverse Events (Safety and Tolerability)
Time frame: 24 weeks
Numer of AE, SAE and Device-related Adverse Events
3 secondary outcomes
Change in the monthly number of monthly headache days from weeks 1-4 to weeks 9-12.
Time frame: 12 weeks
Change in monthly mean number of migraine days from baseline to weeks 21-24
Time frame: 24 weeks
Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 9-12.
Time frame: 12 weeks
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 22 Nov 2024.
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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.
Alit Stark Inbar principal investigator
Theranica
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 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 6 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 22 Nov 2024. 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?
Change in monthly mean number of migraine days from baseline to weeks 9-12 of the study. (time frame: 12 weeks). 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?
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 22 Nov 2024.