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Completed

NCT Number: NCT00135122

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

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tension-Type Headache

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sørlandet Sykehus HF

Kristiansand, Vest-Agder, 4604, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

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

Other names: Prednison, prednisolon

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 25, 2005
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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