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
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014