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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00918671
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : December 30, 2010
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Medication Overuse Headache Other: No new specific intervention

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Medication-overuse Headache: 4 Years Follow up
Study Start Date : January 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Medication-overuse headache
Chronic daily headache combined with medication overuse
 Other: No new specific intervention
No new specific intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change of Medication Days/Month Compared to Baseline [ Time Frame: Baseline and after 4 years' of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Randomized during the initial trial during 2004-2006.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918671


Locations
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Norway
Norwegian National headache Centre, NTNU
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Study Chair: Knut Hagen, MD, PhD Norwegian University of Science and Technology
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00918671    
Other Study ID Numbers: 4.2007.2192
4.2007.2192
07/4471
17429
First Posted: June 11, 2009    Key Record Dates
Results First Posted: December 30, 2010
Last Update Posted: December 2, 2020
Last Verified: November 2020
Keywords provided by Norwegian University of Science and Technology:
Headache
Medication overuse
chronic
relapse
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Headache
Pain
Neurologic Manifestations
 Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases