Migraine Treatment With Nerivio Migra Neurostimulation Device

NCT03076515 | Terminated Results DMC FDA Device

• 1 other identifier: TCH_002
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pain Relief 2 Hours Post Treatment

  Percentage of participants reporting pain relief from pain (pain reduction from 3 or 2 to 1 or 0 or pain reduction from 1 to 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks

  2 hours post treatment

Study Arms (2)

Nerivio Migra active

ACTIVE COMPARATOR

This arm will use the active device for acute treatment of migraine at the migraine symptoms onset. the device will be applied on the upper arm and controlled by a dedicated smartphone application.

Device: Nerivio Migra neurostimulation

Nerivio Migra placebo

SHAM COMPARATOR

This arm will use the sham device for acute treatment of migraine at the migraine symptoms onset. the device will be applied on the upper arm and controlled by a dedicated smartphone application.

Device: Sham Nerivio Migra

Interventions

Nerivio Migra neurostimulation DEVICE

transcutaneous electrical stimulation

Nerivio Migra active

Sham Nerivio Migra DEVICE

electrical stimulation- shame mode

Nerivio Migra placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18-75 years old.
• Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
• Patients reporting 2-8 migraine attacks per month.
• Patient must be able and willing to comply with the protocol.
• Patient must be able and willing to provide written informed consent.
• Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study

You may not qualify if:

• Has other significant pain problem that in the opinion of the investigator may confound the study assessments
• Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
• Known uncontrolled epilepsy.
• Use of Cannabis including medical use.
• Has chronic migraine (more than 15 headache days per month).
• Changed usage or dosage of migraine preventive medications in the last two months
• Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
• Is participating in any other clinical study. -

Sponsors & Collaborators

• Theranica: lead

Study Sites (8)

MedStar - Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Hartford Healthcare Headache Center

Hartford, New York, 06103, United States

Location

Northwell Health, Inc

New York, New York, 11042, United States

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

Herzeliya medical Center

Herzliya, Israel

Location

Maccabi Healthcare neurology clinics

Kfar Saba, Israel

Location

Western Galilee Medical Center

Nahariya, Israel

Location

Limitations and Caveats

Study was terminated following an interim analysis based on 25% of the target study sample size (performed on September 3rd, 2017). Interim analysis showed major protocol deviation in both study arms, both in treatment start time (from onset of migraine attack) and use of concomitant medications, technically considered as failure. Hence, The DMC decision was to terminate the study due to futility.

Results Point of Contact

• Title: Dagan Harris
• Organization: Theranica Bio-Electronics Ltd

daganh@theranica.com

+972723909755

Study Officials

• Brian M Grosberg, MD

  Hartford Healthcare Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 10, 2017
• Study Start: April 2, 2017
• Primary Completion: January 31, 2018
• Study Completion: April 1, 2018
• Last Updated: July 17, 2025
• Results First Posted: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); IL (4)