Clinical Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Brief Summary: The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.

Detailed Summary:
Sponsor: Autonomic Technologies, Inc.

Current Primary Outcome:

  • Number of device related Serious Adverse Events (SAEs) [ Time Frame: Implant through the Experimental Period ]
  • Acute Pain Relief response (as defined by patient) [ Time Frame: 15 minutes ]


Original Primary Outcome:

  • Number of device related serious Adverse Events (AEs) [ Time Frame: 15 minutes ]
  • Acute Pain Relief response (as defined by patient) [ Time Frame: 15 minutes ]


Current Secondary Outcome:

  • Pain Freedom [ Time Frame: 15 minutes ]
  • Rescue medication use [ Time Frame: 90 minutes ]
    Use of medications to treat headache pain within 90 minutes after initiating therapy.
  • Pain Relief after initiating therapy [ Time Frame: 30 minutes ]
  • Pain Relief after initiating therapy [ Time Frame: 60 minutes ]
  • Pain Relief after initiating therapy [ Time Frame: 90 minutes ]


Original Secondary Outcome: Same as current

Information By: Autonomic Technologies, Inc.

Dates:
Date Received: December 3, 2010
Date Started: December 2010
Date Completion:
Last Updated: December 28, 2015
Last Verified: December 2015