EUCTR2017-004187-35-SE进行中（未招募）1 期
The FACE (Facial nerve palsy And Cortisone Evaluation) study in children: a randomised double-blind, placebo-controlled, multicenter trial.
Falun Hospital0 个研究点目标入组 500 人开始时间: 2018年10月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.1-17 years of age
- •2.Acute peripheral facial nerve palsy
- •3.Less than 72 hours of duration of symptoms
- •4.Signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •2.Central facial nerve palsy
- •3.Malformations in head and neck
- •4.Conditions not compatible with cortisone treatment (hypertension, diabetes mellitus type 1, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
- •5.Current or past oncological diagnosis
- •6.Other serious medical conditions (meningitis, encephalitis, stroke)
- •7.Acute otitis media
- •8.Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
- •9.Pregnancy or breastfeeding
- •10.Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
- •11.Immunization with live vaccine 1 month prior onset of symptoms
- •12.Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
- •13.Evaluation of primary endpoint at 12 months not feasible for any reason
- •14.Previously included into the FACE study
研究者
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