Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Medium-load working memory performance
研究概览
简要总结
Proof-of-concept study on the effects of 10 mg fampridine (oral administration) on working memory in healthy participants.
The hypotheses is that fampridine improves working memory performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •generally healthy
- •normotensive (BP between 90/60 mmHg and 140/90 mmHg)
- •BMI between 19 and 29,9 kg/m2
- •aged between 18 and 30 years
- •fluent German-speaking
- •Informed consent as documented by signature
排除标准
- •contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to 4-aminopyridine
- •use of potassium channel blockers within the last 3 months
- •concomitant treatment with OCT 2 inhibitors (e.g. cimetidine, propranolol)
- •acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency)
- •acute cerebrovascular condition
- •history of seizures
- •risk of lowered seizure threshold (due to e.g. sleep deprivation, withdrawal of alcohol after alcohol abuse)
- •renal impairment
- •history of malignant cancers
- •walking problems (e.g. due to dizziness)
- •other clinically significant concomitant disease states (e.g. hepatic dysfunction, cardiovascular disease, diabetes, asthma)
- •clinically significant laboratory or ECG abnormality that could be a safety issue in the study
- •known or suspected non-compliance
- •drug or alcohol abuse
- •inability to follow the procedures of the study, e.g. due to language or psychological problems of the participant
- •participation in another study with an investigational drug within the 30 days preceding and during the present study
- •prior participation (less than two years ago) in a study investigating working memory (notably the n-back task)
- •enrolment of the investigator, his/her family members, employees and other dependent persons
- •smoking (>3 cigarettes per day)
- •intake of psychoactive drugs (e.g. benzodiazepines, antidepressants, neuroleptics)
- •pregnancy or breast feeding
研究组 & 干预措施
Placebo
Identically looking placebo tablets consisting of the identical additives formulated for oral administration.
干预措施: Placebo (Drug)
Fampridine SR
Single oral administration of a tablet fampridine (10 mg) formulated for oral administration taken once in the morning without food. Tablets must be administered whole.
The single intake is followed by a washout period of at least 7 days equalling over 40 half-lives of the active substance fampridine (t½ = 3.61 h) between experimental and control intervention.
干预措施: Fampridine SR (Drug)
结局指标
主要结局
Medium-load working memory performance
时间窗: test day 1 and 2, each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
Accuracy as assessed by a letter n-back task (Papassotiropoulos, Henke et al. 2011) with the levels 0-back and 2-back. This test includes a 2-back task assessing working memory and a 0-back task ('x-target' task) measuring concentration. The 2-back task requires participants to respond to a letter repeat with one intervening letter (for example, S-m-s-g...). The 'x-target' task requires participants to respond to the occurrence of the letter 'x' in a sequence of letters (for example, N-l-X-g...). Accuracy (i.e. correct 2-back responses minus correct 0-back responses) will be calculated.
次要结局
- Bochumer Matrizentest (BOMAT - advanced -short)(test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition)
- N-back with a 3-back condition(test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition)
- Symbol Digit Modalities Test, SDMT(test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition)
- Digit Span Task(test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition)
- Reaction time(test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition)
研究者
Prof. Dominique de Quervain, MD
Director Division of Cognitive Neuroscience
University of Basel