NCT04828707

Brief Summary

Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention. The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases. The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase. Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase. The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 15, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

March 30, 2021

Results QC Date

January 18, 2023

Last Update Submit

February 18, 2023

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

  • Reduction in Migraine Days

    The mean reduction in the number of migraine days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A migraine day is defined as a calendar day with a headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.

    3 months

  • Rate of Adverse Events (Safety and Tolerability)

    Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and Device-related Adverse Events

    3 months

Secondary Outcomes (5)

  • Reduction in Moderate/Severe Headache Days

    3 months

  • Reduction Headache Days

    3 months

  • Reduction of 50% in Headache Days

    3 months

  • Increase in Headache Impact Test-6 (HIT-6) Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the HIT-6 Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)

    3 months

  • Reduction in Migraine-Specific Quality-of-Life (MSQ) Questionnaire Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the MSQ Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)

    3 months

Other Outcomes (6)

  • Reduction in Migraine Medication Intake

    3 months

  • Percentage of Freedom From Headache Post 2 Hours Following Prodrome Treatment

    2 hours post treatment at follow up phase

  • Percentage of Freedom From Headache Post 24 Hours Following Prodrome Treatment

    24 hours post treatment at follow up phase

  • +3 more other outcomes

Study Arms (2)

Migraine prevention treatment with active Nerivio

ACTIVE COMPARATOR

Participants will treat with an active Nerivio device every other day for migraine prevention.

Device: Nerivio active device

Migraine prevention treatment with sham Nerivio

SHAM COMPARATOR

Participants will treat with a sham (placebo) Nerivio device every other day for migraine prevention.

Device: Nerivio sham device

Interventions

Nerivio active deviceDEVICE

Nerivio neurostimulator of conditional pain modulation (CPM)

Migraine prevention treatment with active Nerivio
Nerivio sham deviceDEVICE

Nerivio neurostimulator with an electrical output not intended for neurostimulation

Migraine prevention treatment with sham Nerivio

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years old.
  • Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of Headache Days(HD)/ month with migraine days (migraine with or without aura) at least 8 days/ month for \> 3 months) or non-chronic migraine.
  • History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
  • Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
  • Have personal access to a smartphone (24/7).
  • Must be able and willing to comply with the protocol.
  • Must be able and willing to provide informed consent..

You may not qualify if:

  • An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
  • Uncontrolled epilepsy.
  • History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
  • Current participation in any other interventional clinical study
  • Subject without basic cognitive and motor skills required for operating a smartphone.
  • Pregnant or breastfeeding.
  • Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
  • Prior experience with the Nerivio device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Evolve Clinical Research

Phoenix, Arizona, 85013, United States

Location

The Neurology Center of Southern California

Carlsbad, California, 92011, United States

Location

Newport Beach Clinical Research Associates

Newport Beach, California, 92663, United States

Location

Hartford Headache Center

Hartford, Connecticut, 06107, United States

Location

RecioMed Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157, United States

Location

Chicago Headache Center and Research Institute

Chicago, Illinois, 60657, United States

Location

Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42001, United States

Location

Headache Neurology Research Institute

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

ClinVest Research

Springfield, Missouri, 65810, United States

Location

Ocean medical research

Toms River, New Jersey, 08755, United States

Location

DENT Neurosciences Research Center

Amherst, New York, 14226, United States

Location

Prevention & Strengthening Solutions, Inc.

Columbia, South Carolina, 29203, United States

Location

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

  • Monteith TS, Stark-Inbar A, Shmuely S, Harris D, Garas S, Ironi A, Kalika P, Irwin SL. Remote electrical neuromodulation (REN) wearable device for adolescents with migraine: a real-world study of high-frequency abortive treatment suggests preventive effects. Front Pain Res (Lausanne). 2023 Nov 6;4:1247313. doi: 10.3389/fpain.2023.1247313. eCollection 2023.

    PMID: 38028429DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

No limitations or caveats to report

Results Point of Contact

Title
Dr Dagan Harris. VP Clinical & Regulatory Affairs
Organization
Theranica Bio-Electronics Ltd
daganh@theranica.com
+972723909755

Study Officials

  • Robert Cowan, MD

    Stanford Health Care

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, sham-controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 2, 2021

Study Start

April 13, 2021

Primary Completion

August 31, 2022

Study Completion

October 10, 2022

Last Updated

March 15, 2023

Results First Posted

March 15, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(16)