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
  Purpose

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 Intervention
Headache
Drug: Betablockers or other preventive drugs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Our primary outcome measures were the change, compared to the baseline period, in headache days. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159588

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

Publications:
Responsible Party: Knut Hagen, Professor, Norwegian National Headache Centre, St. Olavs Hospital, Trondheim, Norway
ClinicalTrials.gov Identifier: NCT00159588     History of Changes
Other Study ID Numbers: 2004/534, No relevant
Study First Received: September 9, 2005
Last Updated: February 27, 2014
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014