Clinical trial NCT05940870: A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.
Official title: A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: migraine prevention
Remote electrical neuromodulation
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2023-07-11
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Migraine patients aged 12 or above who were prescribed Nerivio for prevention or dual use treatment of migraine

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in monthly mean number of migraine days from baseline to weeks 9-12 of the study.
timeFrame: 12 weeks
measure: Rate of Adverse Events (Safety and Tolerability)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in the monthly number of monthly headache days from weeks 1-4 to weeks 9-12.
timeFrame: 12 weeks
measure: Change in monthly mean number of migraine days from baseline to weeks 21-24
timeFrame: 24 weeks
measure: Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 9-12.
timeFrame: 12 weeks
Other outcomes:
measure: Change in the number of monthly headache days from weeks 1-4 to weeks 21-24.
timeFrame: 24 weeks
measure: Change in the monthly mean number of prescription acute medication days from weeks 1-4 to weeks 21-24.
timeFrame: 24 weeks
measure: Change in monthly mean number of migraine days from baseline to weeks 21-24 of the study.
timeFrame: 24 weeks
measure: Change in the monthly mean number of presenteeism days during the study.
timeFrame: 24 weeks
measure: Change in the monthly mean number of absenteeism days during the study
timeFrame: 24 weeks
measure: Adherence to treatment
timeFrame: 24 weeks
measure: Change in the Patient Global Impression of Severity from baseline to the end of weeks 2 and 24
timeFrame: 24 weeks
measure: Change in the Patient Global Impression of Change from baseline to the end of weeks 2 and 24
timeFrame: 24 weeks
measure: Self report of tolerability
timeFrame: 24 weeks
measure: Prediction of a migraine day
timeFrame: 24 weeks
Locations:
city: Bridgewater
country: United States
facility: Theranica Inc USA
state: New Jersey
Study officials:
affiliation: Theranica
name: Alit Stark Inbar
role: PRINCIPAL_INVESTIGATOR
References: