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

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Betablockers or other preventive drugs based on primary headache type
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Medication-overuse headache, preventative medication, controls, follow-up, randomized, abrupt withdrawal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Knut Hagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Other

Arm Label

Prophylaxis from the start

Abrupt withdrawal

Controls

Arm Description

Use of preventive drugs from the start without abrupt withdrawal

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

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

Outcomes

Primary Outcome Measures

Headache Days
Change in Headache days per month

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
December 28, 2021
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00159588
Brief Title
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
Official Title
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Medication-overuse headache, preventative medication, controls, follow-up, randomized, abrupt withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylaxis from the start
Arm Type
Active Comparator
Arm Description
Use of preventive drugs from the start without abrupt withdrawal
Arm Title
Abrupt withdrawal
Arm Type
Other
Arm Description
Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week
Arm Title
Controls
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Betablockers or other preventive drugs based on primary headache type
Other Intervention Name(s)
angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin
Intervention Description
Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
Primary Outcome Measure Information:
Title
Headache Days
Description
Change in Headache days per month
Time Frame
5 month
Secondary Outcome Measure Information:
Title
Headache Index
Description
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
Time Frame
5-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Hagen, MD; PhD,
Organizational Affiliation
Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Knut Hagen
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
18823363
Citation
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.
Results Reference
result
PubMed Identifier
21711255
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.
Results Reference
result

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

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