Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedSeptember 12, 2008
September 1, 2008
3.3 years
August 24, 2005
September 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 days
Secondary Outcomes (1)
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.
1 month
Study Arms (1)
2
PLACEBO COMPARATORPlacebo in six days
Interventions
Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6
Eligibility Criteria
You may qualify if:
- Chronic daily headache and medication overuse fulfilling International Headache Society (IHS)-II criteria
You may not qualify if:
- Pregnancy
- Age under 18 and over 70 years
- Major mental disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sørlandet Sykehus HF
Kristiansand, Vest-Agder, 4604, Norway
Related Publications (1)
Boe MG, Mygland A, Salvesen R. Prednisolone does not reduce withdrawal headache: a randomized, double-blind study. Neurology. 2007 Jul 3;69(1):26-31. doi: 10.1212/01.wnl.0000263652.46222.e8. Epub 2007 May 2.
PMID: 17475943RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rolf Salvesen, Professor
University of Tromso
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 25, 2005
Study Start
September 1, 2003
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
September 12, 2008
Record last verified: 2008-09