Medication-overuse Headache: 4 Years Follow up

Medication Overuse Headache Clinical Trial

— MOHfollowup  

Official title:

Treatment of Medication-overuse Headache: 4 Years Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918671
• Other study ID #: 4.2007.2192
• Secondary ID: 4.2007.219207/44
• Status: Completed
• Start date: January 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 74 Years

Eligibility

Inclusion Criteria:

• Randomized during the initial trial during 2004-2006.

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Intervention

Other:
• No new specific intervention
No new specific intervention

Locations

Country	Name	City	State
Norway	Norwegian National headache Centre, NTNU	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Hagen K, Albretsen C, Vilming ST, Salvesen R, Grønning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. A 4-year follow-up of patients with medication-overuse headache previously included in a randomized multicentre study. J Headache Pain. 2011 Jun;12(3):315 — View Citation

Hagen K, Albretsen C, Vilming ST, Salvesen R, Grønning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24. — View Citation

Hagen K, Stovner LJ. A randomized controlled trial on medication-overuse headache: outcome after 1 and 4 years. Acta Neurol Scand Suppl. 2011;(191):38-43. doi: 10.1111/j.1600-0404.2011.01542.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Days/Month After 4 Years Compared to Baseline	Change in headache days/month after 4 years compared to baseline	Baseline and after 4 years
Secondary	Change of Medication Days/Month Compared to Baseline		Baseline and after 4 years' of follow-up