Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

NCT04089761 | Terminated Results DMC FDA Device

• 1 other identifier: TCH004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 12

Brief Summary

Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. This is a prospective, single arm, open label, multicenter trial of the safety and efficacy of Nerivio™ for the acute treatment of migraine in adolescents The study will be conducted in three phases: Phase I - Run-in: Phase II - Treatment phase: Phase III (optional) - Free-use

Conditions

Acute Migraine

Keywords

Migraine treatment, Adolescence

Outcome Measures

Primary Outcomes (1)

• Safety of Nerivio Device

  Number of Participants with Device-Related Adverse Events

  12 weeks

Secondary Outcomes (5)

• Pain Relief at 2 Hours Post Treatment

  2 hours post treatment

• Pain-free at 2 Hours Post Treatment

  2 hours post treatment

• Disappearance of Nausea at 2 Hours Post-treatment

  2 hours post treatment

• Disappearance of Photophobia at 2 Hours Post Treatment

  2 hors post treatment

• Disappearance of Phonophobia at 2 Hours Post Treatment

  2 hours post treatment

Other Outcomes (4)

• Sustained Pain Relief at 24 Hours Post Treatment

  24 hours post treatment

• Sustained Pain Free at 24 Hours Post Treatment

  24 hours post treatment

• Functional Disability at 2 Hours Post Treatment

  2 hours post treatment

Study Arms (1)

Active Device

EXPERIMENTAL

Treatment of acute migraine with an active form of Nerivio device

Device: Nerivio

Interventions

Nerivio DEVICE

Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device 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.

Active Device

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Participants age 12-17 years old at the time of informed consent, inclusive. 2. Participants have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura 3. History of at least 3 migraine attacks per month for each of the 2 months preceding study enrolment 4. Typical headache duration of at least 3 hours (when untreated or unsuccessfully treatment) 5. Stable migraine preventive medications during the 2 months prior to enrollment (no change in usage or dosage).
• \. Participants have personal access to a smartphone (24/7) 7. Participants must be able and willing to comply with the protocol 8. Parents/Guardians must be able and willing to provide written informed consent 9. Participants must be able and willing to provide informed assent

You may not qualify if:

• Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
• Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
• Participants with epilepsy.
• Medical use of cannabis or recreational use one month prior to enrollment.
• Participants who have undergone nerve block (occipital or other) in the head or neck within the last 2 weeks
• Treatment with onabotulinum toxin A (Botox) to the head and/or neck for 3 months before enrollment and/or during the study
• Any history of anti-CGRP antibody treatment
• Current participation in any other clinical study that includes treatment
• Participants without basic cognitive and motor skills required for operating a smartphone.
• Pregnant or breastfeeding females
• Pure menstrual migraine
• Participants who received parenteral treatments for migraine within the previous 2 weeks.
• Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
• Participants who have previous experience with the device
• Participants with arm circumference below 7.9 inches (20 cm)

Sponsors & Collaborators

• Theranica: lead

Study Sites (12)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Clinical Trials Solutions

Hialeah, Florida, 33012, United States

Location

Nicklaus children hospital

Miami, Florida, 33155, United States

Location

PANDA neurology

Atlanta, Georgia, 30328, United States

Location

Children Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Children Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

DENT neurology clinic

Amherst, New York, 14226980, United States

Location

NYU Langone-Health

New York, New York, 10017, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19178, United States

Location

Mercury Clinical Research

Houston, Texas, 77036, United States

Location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77094, United States

Location

Related Publications (1)

• Hershey AD, Irwin S, Rabany L, Gruper Y, Ironi A, Harris D, Sharon R, McVige J. Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis. Pain Med. 2022 Apr 8;23(4):815-820. doi: 10.1093/pm/pnab197.

  PMID: 34185084 DERIVED

Limitations and Caveats

Due to the outbreak of the COVID-19 pandemic in the USA, the enrollment of new patients was forced to be stopped. An interim analysis was conducted at that point, to assess the statistical power of the data accumulated from the 60 patients enrolled which is approximately 50% of the planned sample size. Based on the results of this analysis, the data monitoring committee (DMC) determined that the study can be deemed completed for benefit

Results Point of Contact

• Title: Dr Dagan Harris. VP Clinical and Regulatory Affairs
• Organization: Theranica Bio-Electronics Ltd

daganh@theranica.com

+972723909755

Study Officials

• Andrew Hershey, MD

  Director, Headache Center Cincinnati Children's Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm, open-label, multicenter study

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: October 1, 2019
• Primary Completion: May 10, 2020
• Study Completion: May 24, 2020
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)