NCT00135122已完成3 期
Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy
Sorlandet Hospital HF1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary endpoint was a calculated mean headache (MH), based on number of days with headache and mean intensity of headache during the first six days after withdrawal.
研究概览
简要总结
The purpose of this study is to determine whether prednisolone is more effective than placebo in the first six days after initiation of medication withdrawal therapy for a medication overuse headache. Another purpose is to study whether patients followed by a neurologist 1 year after withdrawal do better than patients followed by a general practitioner.
详细描述
Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic daily headache and medication overuse fulfilling International Headache Society (IHS)-II criteria
排除标准
- •Pregnancy
- •Age under 18 and over 70 years
- •Major mental disorders
研究组 & 干预措施
2
Placebo Comparator
Placebo in six days
干预措施: prednisolone (Drug)
结局指标
主要结局
The primary endpoint was a calculated mean headache (MH), based on number of days with headache and mean intensity of headache during the first six days after withdrawal.
时间窗: 6 days
次要结局
- number of days with zero or mild headache, days with moderate to strong headache, days without headache, Use of antiemetic drugs ,staying drug-free during the entire period.(1 month)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy Predimenol for HeadacheHeadacheNCT06558006Dexa Medica Group60
已完成
3 期
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative ColitisUlcerative ColitisNCT00299013Alizyme796
已完成
4 期
Short Course Glucocorticoid Treatment for PTSDPost-traumatic Stress DisorderNCT00204737University of Wisconsin, Madison12
已完成
2 期
Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary SyndromeHantavirus InfectionsNCT00128180University of New Mexico66
已完成
4 期
A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract SurgeryCataract SurgeryNCT00170729Novartis62