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

Phase 3

Completed

• Conditions: Headache
• Interventions: Drug: prednisolone

• Registration Number: NCT00135122
• Lead Sponsor: Sorlandet Hospital HF

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 Description

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

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-25
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-11
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	prednisolone	Placebo in six days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sørlandet Sykehus HF; 🇳🇴 Kristiansand, Vest-Agder, Norway