Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
Information source: Sorlandet Hospital HF
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Headache
Intervention: prednisolone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sorlandet Hospital HF Official(s) and/or principal investigator(s):
Rolf Salvesen, Professor, Study Chair, Affiliation: University of Tromso
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.
Clinical Details
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 Successful Withdrawal Therapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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.
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.
Detailed description:
Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic daily headache and medication overuse fulfilling International Headache
Society (IHS)-II criteria
Exclusion Criteria:
- Pregnancy
- Age under 18 and over 70 years
- Major mental disorders
Locations and Contacts
Sørlandet Sykehus HF, Kristiansand, Vest-Agder 4604, Norway
Additional Information
Starting date: September 2003
Last updated: September 11, 2008
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