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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135122

Enrollment

100

Registered

2005-08-25

Start date

2003-09-30

Completion date

2007-01-31

Last updated

2008-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache

Keywords

migraine, analgesics, tension type headache

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

Interventions

DRUGprednisolone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026