Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?

This study has been completed.
Sponsor:
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00159588
First received: September 9, 2005
Last updated: February 27, 2014
Last verified: February 2014

September 9, 2005
February 27, 2014
January 2004
November 2006   (final data collection date for primary outcome measure)
Our primary outcome measures were the change, compared to the baseline period, in headache days. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Patients included in the group "preventative medication" have less headache days per month than those with "abrupt withdrawal" after 5 and 12 months follow-up.
Complete list of historical versions of study NCT00159588 on ClinicalTrials.gov Archive Site
Our secondary outcome measures were: (i) change in days with analgesics use per month, (ii) change in "headache index (HI)", (iii) change in sick leave days per month, iv) change in anxiety and depression, v) change in SF-12. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Patients included in the groups "preventative medication" and "abrupt withdrawal" have less headache days per month than those included as "controls" after 5 months follow-up.
Not Provided
Not Provided
 
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.

It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.

This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included.

The included patients were randomized to one out of three possible options:

  1. Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up.
  2. Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
  3. No specific treatment (controls), 5 month follow-up.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Headache
Drug: Betablockers or other preventive drugs
Several preventive drugs based on each individual
  • Active Comparator: 1
    Use of preventive drugs from the start without abrupt withdrawal
    Intervention: Drug: Betablockers or other preventive drugs
  • No Intervention: 2
    Device: Abrupt withdrawal
  • No Intervention: 3
    Active control: No instruction for abrupt withdrawal or prophylactic treatment
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. Epub 2008 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
December 2007
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • fulfill 8.2.7 probably medication-overuse headache according to the International Classification of headache disorders, 2th Edition (2004)

Exclusion Criteria:

  • No benefit of all available preventative medications, no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused, cluster headache, CPH or hemicrania continua, pregnant, use of pain killers of other reasons than headache, other reasons for chronic daily headache than medication-overuse.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00159588
2004/534, No relevant
No
Knut Hagen, Professor, Norwegian National Headache Centre, St. Olavs Hospital, Trondheim, Norway
Norwegian University of Science and Technology
Not Provided
Study Chair: Knut Hagen, MD; PhD, Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway
Norwegian University of Science and Technology
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP