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

2021年12月28日更新者：Norwegian University of Science and Technology

Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.

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.

研究概览

地位

完全的

条件

头痛

干预/治疗

药品：Betablockers or other preventive drugs based on primary headache type

详细说明

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.

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

挪威
- - Trondheim、挪威、7006
    - Knut Hagen

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Prophylaxis from the start Use of preventive drugs from the start without abrupt withdrawal	药品：Betablockers or other preventive drugs based on primary headache type Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin) 其他名称： angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin
其他：Abrupt withdrawal Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week	药品：Betablockers or other preventive drugs based on primary headache type Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin) 其他名称： angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin
其他：Controls 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	药品：Betablockers or other preventive drugs based on primary headache type Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin) 其他名称： angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Headache Days 大体时间：5 month	Change in Headache days per month	5 month

次要结果测量

结果测量	措施说明	大体时间
Headache Index 大体时间：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	5-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Norwegian University of Science and Technology

调查人员

学习椅：Knut Hagen, MD; PhD,、Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年1月1日

初级完成 (实际的)

2006年11月1日

研究完成 (实际的)

2007年12月1日

研究注册日期

首次提交

2005年9月9日

首先提交符合 QC 标准的

2005年9月9日

首次发布 (估计)

2005年9月12日

研究记录更新

最后更新发布 (实际的)

2022年3月11日

上次提交的符合 QC 标准的更新

2021年12月28日

最后验证

2021年12月1日

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