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An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Serra Gerardo, Ospedale Sacro Cuore - Don Calabria
ClinicalTrials.gov Identifier:
NCT00407992
First received: December 4, 2006
Last updated: August 29, 2011
Last verified: August 2011
History of Changes

December 4, 2006
August 29, 2011
December 2006
December 2010   (final data collection date for primary outcome measure)
  • Number and the type of adverse events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
  • Reduction of headache frequency and intensity [ Time Frame: Study period ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00407992 on ClinicalTrials.gov Archive Site
  • Reduction in drug intake [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Changes in QoL and interference in everyday activities [ Time Frame: Study period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Headache, Migraine
  • Device: Occipital nerve stimulation ON
    Implant of an occipital nerve stimulator switched ON
  • Device: Occipital nerve stimulation off
    Implant of an occipital nerve stimulator switched OFF
  • Experimental: Occipital nerve stimulation ON
    Intervention: Device: Occipital nerve stimulation ON
  • Occipital nerve stimulation OFF
    Intervention: Device: Occipital nerve stimulation off
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with migraine
  • patients 18 years aged or above

Exclusion Criteria:

  • patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
  • patients pregnant or planning on becoming pregnant during the study period
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00407992
MFGGL113006
Not Provided
Serra Gerardo, Ospedale Sacro Cuore - Don Calabria
Ospedale Sacro Cuore - Don Calabria
Not Provided
Principal Investigator: Gerardo Serra Ospedale Sacro Cuore - Don Calabria
Ospedale Sacro Cuore - Don Calabria
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP