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

Primary Purpose

Headache

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
prednisolone
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring migraine, analgesics, tension type headache

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sørlandet Sykehus HF

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

2

Arm Description

Placebo in six days

Outcomes

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.

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.

Full Information

First Posted
August 24, 2005
Last Updated
September 11, 2008
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT00135122
Brief Title
Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
migraine, analgesics, tension type headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo in six days
Intervention Type
Drug
Intervention Name(s)
prednisolone
Other Intervention Name(s)
Prednison, prednisolon
Intervention Description
Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Salvesen, Professor
Organizational Affiliation
University of Tromso
Official's Role
Study Chair
Facility Information:
Facility Name
Sørlandet Sykehus HF
City
Kristiansand
State/Province
Vest-Agder
ZIP/Postal Code
4604
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17475943
Citation
Boe MG, Mygland A, Salvesen R. Prednisolone does not reduce withdrawal headache: a randomized, double-blind study. Neurology. 2007 Jul 3;69(1):26-31. doi: 10.1212/01.wnl.0000263652.46222.e8. Epub 2007 May 2.
Results Reference
result

Learn more about this trial

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

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