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

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ClinicalTrials.gov Identifier: NCT00159588
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 19, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Headache Drug: Betablockers or other preventive drugs

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
Study Start Date : January 2004
Primary Completion Date : November 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Use of preventive drugs from the start without abrupt withdrawal
Drug: Betablockers or other preventive drugs
Several preventive drugs based on each individual
No Intervention: 2
Device: Abrupt withdrawal
No Intervention: 3
Active control: No instruction for abrupt withdrawal or prophylactic treatment

Outcome Measures

Primary Outcome Measures :
  1. Our primary outcome measures were the change, compared to the baseline period, in headache days. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159588

Knut Hagen
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Study Chair: Knut Hagen, MD; PhD, Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159588     History of Changes
Other Study ID Numbers: 2004/534
No relevant
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
Medication-overuse headache
preventative medication
abrupt withdrawal

Additional relevant MeSH terms:
Headache Disorders, Secondary
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases