A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.

• ClinicalTrials.gov Identifier: NCT05940870
• Recruitment Status: Active, not recruiting
• First Posted: July 11, 2023
• Last Update Posted: January 23, 2024
• Sponsor: Theranica
• Information provided by (Responsible Party): Theranica

Study Description

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

Condition or disease	Intervention/treatment
Migraine	Device: Nerivio

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

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.
• Actual Study Start Date: July 3, 2023
• Estimated Primary Completion Date: March 31, 2024
• Estimated Study Completion Date: May 1, 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Nerivio treatment for migraine prevention; Patients with migraine who recieved the Nerivio device for migraine prevention therapy	Device: Nerivio; Patients with migraine who received the Nerivio device for migraine prevention therapy

Outcome Measures

Primary Outcome Measures :

1. 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.

2. Rate of Adverse Events (Safety and Tolerability) [ Time Frame: 24 weeks ]
   Numer of AE, SAE and Device-related Adverse Events

Secondary Outcome Measures :

1. 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.

2. 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.
3. 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.

Other Outcome Measures:

1. 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
2. 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
3. Change in monthly mean number of migraine days from baseline to weeks 21-24 of the study. [ 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.
4. 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

5. 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.

6. Adherence to treatment [ Time Frame: 24 weeks ]
   Proportion of participants (in percent) treating, on average, at least 10 times per 4-weeks period during the study.
7. Change in the Patient Global Impression of Severity from baseline to the end of weeks 2 and 24 [ Time Frame: 24 weeks ]

   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:

   1. Very much improved
   2. Much improved
   3. Minimally improved
   4. No change
   5. Minimally worse
   6. Much worse
   7. Very much worse
8. 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.
9. Self report of tolerability [ Time Frame: 24 weeks ]

   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?

   1. Completely tolerable
   2. Very tolerable
   3. Moderately tolerable
   4. Slightly tolerable
   5. Not at all tolerable
10. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Migraine patients aged 12 or above who were prescribed Nerivio for prevention or dual use treatment of migraine

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

Contacts and Locations

Locations

United States, New Jersey

Theranica Inc USA

Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Theranica

Investigators

• Principal Investigator: Alit Stark Inbar; Theranica

More Information

• Responsible Party: Theranica
• ClinicalTrials.gov Identifier: NCT05940870
• Other Study ID Numbers: TCH015
• First Posted: July 11, 2023
• Last Update Posted: January 23, 2024
• Last Verified: June 2023

• 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

Keywords provided by Theranica:

migraine prevention; Remote electrical neuromodulation

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases