Clinical Trial: Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache

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

Official Title: Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Suc

Brief Summary: The purpose of this study is to determine whether prednisolone is more effective than placebo in the first six days after initiation of medication withdrawal therapy for a medication overuse headache. Another purpose is to study whether patients followed by a neurologist 1 year after withdrawal do better than patients followed by a general practitioner.

Detailed Summary: Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31
Sponsor: Sorlandet Hospital HF

Current Primary Outcome: The primary endpoint was a calculated mean headache (MH), based on number of days with headache and mean intensity of headache during the first six days after withdrawal. [ Time Frame: 6 days ]

Original Primary Outcome:

Current Secondary Outcome: number of days with zero or mild headache, days with moderate to strong headache, days without headache, Use of antiemetic drugs ,staying drug-free during the entire period. [ Time Frame: 1 month ]

Original Secondary Outcome:

Information By: Sorlandet Hospital HF

Dates:
Date Received: August 24, 2005
Date Started: September 2003
Date Completion:
Last Updated: September 11, 2008
Last Verified: September 2008