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

Not Applicable

Completed

• Conditions: Headache
• Interventions: Drug: Betablockers or other preventive drugs based on primary headache type

• Registration Number: NCT00159588
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2006-11
• Study Completion: 2007-12
• Results First Submitted: 2021-10-26
• Results First Submitted QC: 2021-10-26
• Status Verified: 2021-12
• Results First Posted: 2021-12-01
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylaxis from the start	Betablockers or other preventive drugs based on primary headache type	Use of preventive drugs from the start without abrupt withdrawal
Controls	Betablockers or other preventive drugs based on primary headache type	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
Abrupt withdrawal	Betablockers or other preventive drugs based on primary headache type	Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week

Primary Outcome Measures

Name	Time	Method
Headache Days	5 month	Change in Headache days per month

Secondary Outcome Measures

Name	Time	Method
Headache Index	5-month follow-up	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

Trial Locations

Locations (1)

Knut Hagen; 🇳🇴 Trondheim, Norway