EUCTR2014-005088-34-GB进行中（未招募）1 期
A randomised controlled, double blind trial investigating the efficacy of fluoxetine treatment in improving memory and learning impairments in patients with mesial temporal lobe epilepsy: Fluoxetine, Learning and Memory in Epilepsy (FLAME). - FLAME
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
入选标准
- •The inclusion criteria for this trial are;
- •Adult patients between the ages of 18-65yrs
- •Adult persons over the age of 65 will not be included as neurogenesis (the postulated biological target) diminishes significantly after this age and this subgroup therefore may not benefit. If benefit is shown under 65 then a subsequent study to assess benefit in this age group may be carried out.
- •diagnosis of mesial temporal lobe epilepsy
- •unilateral hippocampal sclerosis (confirmed by MRI)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion Criteria for this trial are;
- •bilateral hippocampal sclerosis on MRI
- •presence of significant active depression and/ or anxiety as determined by
- •HADS scoring (11 or above on either subscale)
- •Persons lacking capacity or an IQ score of 80 or below as assessed by the
- •presence of poorly controlled seizures in patients undergoing active AED
- •any participant not suitable for MRI
- •Wishing to breast feed during the trial
- •participation in another clinical trial of an investigational medicinal
- •product (IMP)
- •previous adverse reaction to fluoxetine
- •contraindicated concomitant medication – such as Monoamine Oxidase Inhibitors
- •hepatic impairment that would require any dose adjustment for fluoxetine
- •(elevated liver Enzymes (- 2.5 or more times the upper limit of the normal
- •congenital long QT syndrome, a family history of QT prolongation or other
- •clinical conditions that predispose to arrhythmias (e.g., hypokalemia,
- •hypomagnesemia, bradycardia, acute myocardial infarction or uncompensated
- •heart failure). An ECG will be performed in patients with a stable cardiac
- •history. Most patients in our database have already been screeened for
- •prolonged Q-T syndrome as part of their epilepsy evaluation.
- •Patients on Tamoxifen as concomitant Fluoxetine may lead to reduced
- •concentrations of its active metabolite endoxifen.
- •Participants taking St John’s Wort should agree to discontinue it before
- •taking the IMP. If not, they will be excluded, as St John’s Wort potentiates
- •the serotonergic effects of Fluoxetine.
研究者
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