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

Norwegian University of Science and Technology

Status: Completed

Conditions: Headache

Treatments: Drug: Betablockers or other preventive drugs based on primary headache type

Study type: Interventional

Funder types: Other

Identifiers

NCT00159588

NCT00159588

2004/534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

Prophylaxis from the start

Active Comparator group

Description:

Use of preventive drugs from the start without abrupt withdrawal

Treatment:

Drug: Betablockers or other preventive drugs based on primary headache type

Abrupt withdrawal

Other group

Description:

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

Treatment:

Drug: Betablockers or other preventive drugs based on primary headache type

Controls

Other group

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

Treatment:

Drug: Betablockers or other preventive drugs based on primary headache type