drugset / Trial / NCT00159588
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-01
- Primary completion
- 2006-11
- Completion
- 2007-12
Outcome
Missed primary endpoint
registry analysis (superiority test); Prophylaxis From the Start vs Abrupt Withdrawal vs Controls; p = 0.056; Kruskal-Wallis; note: Between-group analysis NCT00159588 ↗
paper The primary outcome measure, change in headache days per month, did not differ significantly between groups. PMID 18823363 ↗
Publications
- Results Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24.
- Results Hagen K, Stovner LJ. A randomized controlled trial on medication-overuse headache: outcome after 1 and 4 years. Acta Neurol Scand Suppl. 2011;(191):38-43. doi: 10.1111/j.1600-0404.2011.01542.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Unknown | — | — |
| Subject | Valproate | Small molecule | — | — |