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

This study has been completed.
Sponsor:
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00918671
First received: June 9, 2009
Last updated: November 30, 2010
Last verified: September 2010
  Purpose

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 Intervention
Medication Overuse Headache
Other: No new specific intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Medication-overuse Headache: 4 Years Follow up

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Reduction of Headache Days/Month at End of Follow-up Compared to Baseline [ Time Frame: 4 years after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of Medication Days/Month Compared to Baseline [ Time Frame: 4 years' of follow-up ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Medication-overuse headache
Chronic daily headache combined with medication overuse
Other: No new specific intervention
No new specific intervention
Other Name: 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.

  Eligibility

Ages Eligible for Study:   22 Years to 74 Years
Genders Eligible for Study:   Both
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
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: NCT00918671

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology, Norwegian University of Science and Technology, 7489 Trondheim
ClinicalTrials.gov Identifier: NCT00918671     History of Changes
Other Study ID Numbers: 4.2007.2192, 4.2007.2192, 07/4471, 17429
Study First Received: June 9, 2009
Results First Received: June 3, 2010
Last Updated: November 30, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Headache
Medication overuse
chronic
relapse

Additional relevant MeSH terms:
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014