Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache

Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135122
• Other study ID #: 70203
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2005
• Last updated: September 11, 2008
• Start date: September 2003
• Est. completion date: January 2007

Study information

• Verified date: September 2008
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary

Intervention

Drug:
• prednisolone
Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6

Locations

Country	Name	City	State
Norway	Sørlandet Sykehus HF	Kristiansand	Vest-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bøe MG, Mygland A, Salvesen R. Prednisolone does not reduce withdrawal headache: a randomized, double-blind study. Neurology. 2007 Jul 3;69(1):26-31. Epub 2007 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No