MedDataX Logo

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

NCT ID: NCT00135122

Last Updated: 2008-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

migraine analgesics tension type headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Placebo in six days

Group Type PLACEBO_COMPARATOR

prednisolone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prednisolone

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prednison, prednisolon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sorlandet hospital HF

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rolf Salvesen, Professor

Role: STUDY_CHAIR

University of Tromso

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sørlandet Sykehus HF

Kristiansand, Vest-Agder, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17475943 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

70203

Identifier Type: -

Identifier Source: org_study_id