Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
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|ClinicalTrials.gov Identifier: NCT00159588|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment|
|Headache||Drug: Betablockers or other preventive drugs|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.|
|Study Start Date :||January 2004|
|Primary Completion Date :||November 2006|
|Study Completion Date :||December 2007|
Active Comparator: 1
Use of preventive drugs from the start without abrupt withdrawal
Drug: Betablockers or other preventive drugs
Several preventive drugs based on each individual
No Intervention: 2
Device: Abrupt withdrawal
No Intervention: 3
Active control: No instruction for abrupt withdrawal or prophylactic treatment
- Our primary outcome measures were the change, compared to the baseline period, in headache days. [ Time Frame: 1 year ]
- Our secondary outcome measures were: (i) change in days with analgesics use per month, (ii) change in "headache index (HI)", (iii) change in sick leave days per month, iv) change in anxiety and depression, v) change in SF-12. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159588
|Trondheim, Norway, 7006|
|Study Chair:||Knut Hagen, MD; PhD,||Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway|