DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Sorlandet Hospital HF
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Headache

Intervention: prednisolone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sorlandet Hospital HF

Official(s) and/or principal investigator(s):
Rolf Salvesen, Professor, Study Chair, Affiliation: University of Tromso


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.

Clinical Details

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

Primary outcome: 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.

Secondary outcome: 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.

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


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Sørlandet Sykehus HF, Kristiansand, Vest-Agder 4604, Norway
Additional Information

Starting date: September 2003
Last updated: September 11, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017