Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache - Full Text View

Sponsor:	Sorlandet Hospital HF
Information provided by:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00135122

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 III

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:

MedlinePlus related topics: Headache

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

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

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:

Bøe MG, Mygland A, Salvesen R. Prednisolone does not reduce withdrawal headache: a randomized, double-blind study. Neurology. 2007 Jul 3;69(1):26-31. Epub 2007 May 2.

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 for Health and Social Affairs

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 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 February 09, 2012