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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Headache

Intervention / Treatment
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* Drug: Betablockers or other preventive drugs based on primary headache type


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prophylaxis from the start<br>Use of preventive drugs from the start without abrupt withdrawal | Drug: Betablockers or other preventive drugs based on primary headache type<br>* Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)<br>* Other names: angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin;|
| Other: Abrupt withdrawal<br>Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week | Drug: Betablockers or other preventive drugs based on primary headache type<br>* Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)<br>* Other names: angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin;|
| Other: Controls<br>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 | Drug: Betablockers or other preventive drugs based on primary headache type<br>* Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)<br>* Other names: angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Days | Change in Headache days per month | 5 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication-overuse headache, preventative medication, controls, follow-up, randomized, abrupt withdrawal