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

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Headache Prescription Drug Abuse

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

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 ]

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 ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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:

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

Keywords provided by Sorlandet Hospital HF:


migraine analgesics tension type headache

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 18, 2017