We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » electroCore’s Migraine Device Reduces Frequency of Headaches in Pilot Study

electroCore’s Migraine Device Reduces Frequency of Headaches in Pilot Study

June 26, 2014

Migraine sufferers treated with gammaCore noninvasive vagus nerve stimulation had fewer headaches than patients treated with a sham device, devicemaker electroCore said Thursday in announcing results of a pilot clinical study.

Patients who remain on the nerve stimulation therapy for longer periods of time may have larger decreases in headache days, the company says. The device, which met the study’s safety endpoint, is intended for the prevention of chronic migraine.

The study enrolled 59 adult migraine patients, all of whom had more than 15 headache days per month in the three months preceding the trial. During a two month double blind comparison, patients were given either an active device or an identical-looking one that did not stimulate the vagus nerve. After a six-month open label phase, 38 percent of gammaCore patients showed a 50 percent reduction in headache days per month, the Basking Ridge, N.J., company says.

Additional studies are now underway, electroCore spokeswoman Jennifer Berman tells Device Daily Bulletin. The company also plans to test the device on epilepsy, irritable bowel syndrome and functional dyspepsia, she says.

The gammaCore is CE-marked and available in Europe and Canada. The company is in the process of seeking FDA approval, Berman adds. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Medical Devices Commercial Operations

Upcoming Events

  • 21Jan

    Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Purple_Approved_Stamp.gif

    Seno Medical Gets Premarket Approval for Breast Cancer Diagnostic

  • Triple Vaccine, needles

    Moderna to Start New Trial Adding Third Shot of COVID-19 Vaccine

  • Supreme Court Rejects Merck’s Appeal for $2.5 Billion Patent Verdict Reinstatement

  • FDA clears text

    FDA Clears SCC’s Transfusion-Management Software

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing