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

Headache Clinical Trial

Official title:

Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159588
• Other study ID #: 2004/534
• Status: Completed
• Phase: N/A
• Start date: January 2004
• Est. completion date: December 2007

Study information

• Verified date: December 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary

Intervention

Drug:
• Betablockers or other preventive drugs based on primary headache type
Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)

Locations

Country	Name	City	State
Norway	Knut Hagen	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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.1468-2982.20 — 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	Headache Days	Change in Headache days per month	5 month
Secondary	Headache Index	Headache index (HI) per month calculated by the sum of products of headache days /month combined with mean daily hours with headache and mean daily headache severity on days with headache. High HI reflect high headache burden	5-month follow-up