Clinical trial NCT00159588: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
Official title: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Keywords: Medication-overuse headache
preventative medication
controls
follow-up
randomized
abrupt withdrawal
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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
* chronic paroxysmal hemicrania
* hemicrania continua, pregnancy
* use of pain killers for other reasons than headache
* other reasons for chronic daily headache than medication-overuse

Primary outcomes:
measure: Headache Days
timeFrame: 5 month
Secondary outcomes:
measure: Headache Index
timeFrame: 5-month follow-up
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Knut Hagen
Study officials:
affiliation: Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway
name: Knut Hagen, MD; PhD,
role: STUDY_CHAIR
References:
citation: Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning 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.
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.