- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940870
A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.
A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Theranica Inc USA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nerivio treatment for migraine prevention
Patients with migraine who recieved the Nerivio device for migraine prevention therapy
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Patients with migraine who received the Nerivio device for migraine prevention therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Adverse Events (Safety and Tolerability)
Time Frame: 24 weeks
|
Numer of AE, SAE and Device-related Adverse Events
|
24 weeks
|
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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the monthly number of monthly headache days from weeks 1-4 to weeks 9-12.
Time Frame: 12 weeks
|
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. |
12 weeks
|
Change in monthly mean number of migraine days from baseline to weeks 21-24
Time Frame: 24 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 21-24 of the study.
|
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
|
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. |
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the monthly mean number of presenteeism days during the study.
Time Frame: 24 weeks
|
Change in number of monthly presenteeism days depicting the change in the number of presenteeism days from weeks 1-4 to that of the subsequent study months. Presenteeism Day: a calendar day on which the participant is at work (or school) with the presence of moderate/severe functional disability |
24 weeks
|
Change in the monthly mean number of absenteeism days during the study
Time Frame: 24 weeks
|
Change in number of monthly absenteeism days depicting the change in the number of absenteeism days from weeks 1-4 to that of the subsequent study months. Absenteeism Day: a calendar day on which the participant is absent from work (or school) due to migraine disability. |
24 weeks
|
Self report of tolerability
Time Frame: 24 weeks
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Change in the Patient's Self report of tolerability during the study period This outcome measure is a single-item self-report scale to assess the patient's subjective experience of the extent to which the treatment was well-tolerated. Scale text: To what extent was the treatment well tolerated?
|
24 weeks
|
Prediction of a migraine day
Time Frame: 24 weeks
|
prediction of a migraine day based on prodromal symptoms.
Predictive accuracy, measured as the difference between the observed values and predicted values of the occurrence of a migraine day in the following (predicted) day.
|
24 weeks
|
Change in the number of monthly headache days from weeks 1-4 to weeks 21-24.
Time Frame: 24 weeks
|
Change in number of monthly headache days depicting the change in the number of headache days from weeks 1-4 to weeks 21-24
|
24 weeks
|
Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 21-24.
Time Frame: 24 weeks
|
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 21-24 of the study
|
24 weeks
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Change in monthly mean number of migraine days from baseline to weeks 21-24 of the study.
Time Frame: 24 weeks
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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.
|
24 weeks
|
Adherence to treatment
Time Frame: 24 weeks
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Proportion of participants (in percent) treating, on average, at least 10 times per 4-weeks period during the study.
|
24 weeks
|
Change in the Patient Global Impression of Severity from baseline to the end of weeks 2 and 24
Time Frame: 24 weeks
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Change in the Patient's Global Impression of Severity (PGI-S) from baseline to the end of weeks 12 and 24. Patient's Global Impression of Severity score scale is a Scale text (single-question scale): Since the start of the study, my overall status is:
|
24 weeks
|
Change in the Patient Global Impression of Change from baseline to the end of weeks 2 and 24
Time Frame: 24 weeks
|
hange in the Patient's Global Impression of Change(PGI-G) from baseline to the end of weeks 12 and 24.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alit Stark Inbar, Theranica
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCH015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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