An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- International Cooperative Ataxia Rating Scale (ICARS)
研究概览
简要总结
The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.
详细描述
This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Friedreich Ataxia
排除标准
- •Unable to provide Informed Consent
研究组 & 干预措施
Bupropion & Citalopram
100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day
干预措施: bupropion & Citalopram (Drug)
Bupropion & Placebo
100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
干预措施: Bupropion & Placebo (Drug)
Placebo & Citalopram
Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
干预措施: Placebo & Citalopram (Drug)
Placebo & Placebo
Placebo & Placebo taken orally one time per day
干预措施: Placebo & Placebo (Drug)
结局指标
主要结局
International Cooperative Ataxia Rating Scale (ICARS)
时间窗: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)
The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.
Friedreich Ataxia Rating Scale (FARS)
时间窗: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.
次要结局
- Comparison of FARS and ICARS(Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion))