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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135122
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : September 12, 2008
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
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 : September 2003
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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 Name: Prednison, prednisolon

Primary Outcome Measures :
  1. 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. [ Time Frame: 6 days ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135122

Sørlandet Sykehus HF
Kristiansand, Vest-Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Study Chair: Rolf Salvesen, Professor University of Tromso

Publications of Results:
Responsible Party: Svein Gunnar Gundersen, Sorlandet hospital HF Identifier: NCT00135122     History of Changes
Other Study ID Numbers: 70203
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: September 12, 2008
Last Verified: September 2008

Keywords provided by Sorlandet Hospital HF:
tension type headache

Additional relevant MeSH terms:
Headache Disorders, Secondary
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents