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

Sponsor

Sorlandet Hospital HF (Other)

Overall Status

Completed

CT.gov ID

NCT00135122

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Headache	Drug: prednisolone	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 2 Placebo in six days	Drug: prednisolone Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6 Other Names: Prednison, prednisolon

Arm

Intervention/Treatment

Placebo Comparator: 2

Placebo in six days

Drug: prednisolone

Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6

Other Names:

Prednison, prednisolon

Outcome Measures

Primary Outcome Measures

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

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]