Clinical Trial: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
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 Summary:
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.
Sponsor: Norwegian University of Science and Technology
Current Primary Outcome: Our primary outcome measures were the change, compared to the baseline period, in headache days. [ Time Frame: 1 year ]
Original Primary Outcome: 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.
Current Secondary Outcome: 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 ]
Original Secondary Outcome: 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.
Information By: Norwegian University of Science and Technology
Dates:
Date Received: September 9, 2005
Date Started: January 2004
Date Completion:
Last Updated: July 18, 2016
Last Verified: July 2016
