DRKS00004716进行中(未招募)3 期
Efficacy and safety of oral prednisone as add-on therapy in prophylactic treatment of episodic cluster headache: a randomized, placebo controlled parallel study. - PredCH
niversitätsklinikum Essen0 个研究点目标入组 118 人开始时间: 2013年2月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •Male and female patients between18 and 65 year of age, of legal competence, with sufficient proficiency of written and spoken German. Willing and capable to attend regular follow-up.
- •Episodic cluster headache according to the IHS-criteria;patient has had at least one previous attack before, average duration of previous cluster episodes at least one month untreated, expected duration of cluster period after randomization should be at least one month after initiation of therapy;
- •previous cluster episodes should be longer than one month away; at least second cluster episode during life-time. Beginning of current bout of Clster headache less than 30 days ago. Last bout more than 30 days ago.
排除标准
- •No other prophylactic drugs than the study medication (prednisone) and verapamil within 30 days before inclusion into study.
- •Pregnancy and nursing. Other severe illnesss,
- •contraindication against prednison or verapamil; chronic cluster headache, Addiction to alcohol or other drugs, Diabetes mellitus, cardiac arrhythmia, osteoporosis, missing consent.
研究者
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