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Completed

NCT Number: NCT00159588

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

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Knut Hagen

Trondheim, 7006, Norway

About this study

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:

  • 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.
  • Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
  • No specific treatment (controls), 5 month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betablockers or other preventive drugs based on primary headache type

Drug

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

Other names: angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin

Primary outcomes

  1. Headache Days

    Time frame: 5 month

    Change in Headache days per month

Secondary outcomes

  1. Headache Index

    Time frame: 5-month follow-up

    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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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