Medication-overuse Headache: 4 Years Follow up (MOHfollowup)

November 16, 2020 updated by: Norwegian University of Science and Technology

Treatment of Medication-overuse Headache: 4 Years Follow up

From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7489
        • Norwegian National headache Centre, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical departments of five University Hospitals in Norway with probable medication overuse headache included in a 1-year open-labeled trial during 2004-2006.

Description

Inclusion Criteria:

  • Randomized during the initial trial during 2004-2006.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medication-overuse headache
Chronic daily headache combined with medication overuse
Other: No new specific intervention
No new specific intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Headache Days/Month After 4 Years Compared to Baseline
Time Frame: Baseline and after 4 years
Change in headache days/month after 4 years compared to baseline
Baseline and after 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Medication Days/Month Compared to Baseline
Time Frame: Baseline and after 4 years' of follow-up
Baseline and after 4 years' of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Chair: Knut Hagen, MD, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.2007.2192
  • 07/4471
  • 17429

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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