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

NCT ID: NCT00159588

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2007-12-31

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prophylaxis from the start

Use of preventive drugs from the start without abrupt withdrawal

Group Type: ACTIVE_COMPARATOR

Betablockers or other preventive drugs based on primary headache type

Intervention 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)

Abrupt withdrawal

Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week

Group Type: OTHER

Betablockers or other preventive drugs based on primary headache type

Intervention 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)

Controls

Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment

Group Type: OTHER

Betablockers or other preventive drugs based on primary headache type

Intervention 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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Knut Hagen, MD; PhD,

Role: STUDY_CHAIR

Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway

Locations

Knut Hagen

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 18823363 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21711255 (View on PubMed)

Other Identifiers

NCT00159588

Identifier Type: -

Identifier Source: secondary_id

2004/534

Identifier Type: -

Identifier Source: org_study_id