It is a common beliefe 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 benifite to use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.

Condition	Intervention
Headache	Drug: Use of preventative medications (e.g beta-blockers....)

Further Study Details: 

Primary Outcomes: Patients included in the group "preventative medication" have less headache days per month than those with "abrupt withdrawal" after 5 and 12 months follow-up.
Secondary Outcomes: Patients included in the groups "preventative medication" and "abrupt withdrawal" have less headache days per month than those included as "controls" after 5 months follow-up.
Expected Total Enrollment:  75

This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. Hopefully, a total of 75 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) will be included in the end of 2006. So fare, 50 patients have been included. At the first visit, the included patients can be randomized to one out of three possible options:

1. Abrupt withdrawal of the acute medication(s) they have been overusing (25 patients). 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 choise) directly without abrupt withdrawal, 12 month follow-up (25 patients).
3. No specific treatment (controls), 5 month follow-up (25 patients).

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• fullfil 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, CPH or hemicrania continua, pregnant, use of pain killers of other reasons than headache, other reasons for chronic daily headache than medication-overuse.

Please refer to this study by ClinicalTrials.gov identifier  NCT00159588

Knut Hagen, MD, PhD      +47 73 59 87 79    knut.hagen@ntnu.no

Norway
      Knut Hagen, Trondheim,  7006,  Norway; Recruiting

Study chairs or principal investigators

Knut Hagen, MD; PhD,,  Study Chair,  Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway   

Study ID Numbers:  2004/534; No relevant
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00159588
Health Authority: Norway: Norwegian Social Science Data Services
ClinicalTrials.gov processed this record on 2005-09-13