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

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00135122
First received: August 24, 2005
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Headache
Drug: prednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

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. [ Time Frame: 6 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2003
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135122

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

Publications:
Responsible Party: Svein Gunnar Gundersen, Sorlandet hospital HF
ClinicalTrials.gov Identifier: NCT00135122     History of Changes
Other Study ID Numbers: 70203
Study First Received: August 24, 2005
Last Updated: September 11, 2008
Health Authority: Norway: Directorate of Health

Keywords provided by Sorlandet Hospital HF:
migraine
analgesics
tension type headache

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

ClinicalTrials.gov processed this record on July 20, 2014