Clinical Trial: Occipital Nerve Stimulation in the Treatment of Migraine

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicenter, Randomized, Controlled, Double-Blind, Proof-of-Concept Study Assessing the Safety and Effectiveness of a Signal Generator Device (NMS EBox) for the Treatmen

Brief Summary: The objective of this proof-of-concept study is to generate initial safety and effectiveness data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in an acute setting. The results of this study will determine if further development of this device in a larger study is warranted.

Detailed Summary:
Sponsor: Ethicon, Inc.

Current Primary Outcome: Reduction of Head Pain Severity [ Time Frame: Over 96-hours treatment period ]

The primary endpoint is overall reduction of head pain severity in subjects with chronic migraine who are treated with the NMS E-Box over a 96-hour treatment period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rates of Reduction in Severity of Head Pain [ Time Frame: Over the 96-hour treatment period ]
    Responder rates for reduction in the severity of head pain associated with chronic migraine over the 96-hour Treatment Period (e.g., 30% and 50% responder rates).
  • Time with No Head Pain [ Time Frame: Over the 96-hour Treatment Period ]
    Increase in cumulative time with no head pain over the 96-hour Treatment Period.
  • Presence of Symptoms [ Time Frame: Over the 96-hour treatment period ]
    Decrease in the presence of each of the following migraine-associated symptoms (i.e., nausea or vomiting; photophobia; phonophobia) over the 96-hour Treatment Period.
  • Severity of Symptoms [ Time Frame: Over the 96-hour treatment period ]
    Decrease in the severity of each of the following migraine-associated symptoms (i.e., nausea or vomiting; photophobia; phonophobia) over the 96-hour Treatment Period.
  • Use of Medication [ Time Frame: Over the 96-hour treatment period ]
    Decrease in the use of any over-the-counter or prescription medication taken for the acute treatment of migraine or head pain over the 96-hour Treatment Period.
  • Impairment [ Time Frame: Over the 96-hour treatment period ]
    Decrease in Migraine-Related Impairment over the 96-hour Treatment Period.
  • Sleep Quality [ Time Frame: Over the 96-hour treatment period ]
    Improvement in Sleep Quality over the 96-hour Treatment Period.
  • PGIC [ Time Frame: End of the 96-hour treatment period ]
    Improvement in the Patient Global Impression of Change (PGIC) for Chronic Migraine at the end of the 96-hour Treatment Period.
  • CGIC [ Time Frame: End of the 96-hour treatment period ]
    Improvement in the Clinician Global Impression of Change (CGIC) for Chronic Migraine at the end of the 96-hour Treatment Period.
  • PGIC Migraine [ Time Frame: End of the 96-hour treatment period ]
    Improvement in the Patient Global Impression of Change for Migraine-Related Impairment at the end of the 96-hour Treatment Period.
  • PGIC Sleep [ Time Frame: End of the 96-hour treatment period ]
    Improvement in the Patient Global Impression Change for Sleep Quality at the end of the 96-hour Treatment Period.


Original Secondary Outcome: Same as current

Information By: Ethicon, Inc.

Dates:
Date Received: May 14, 2013
Date Started: April 2013
Date Completion:
Last Updated: July 15, 2013
Last Verified: June 2013