ACTRN12615000406505已完成2 期
An open-label extension study of oral Triheptanoin as an add-on treatment to adolescent and adult participants with medically refractory epilepsy
niversity of Queensland0 个研究点目标入组 12 人开始时间: 2015年4月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •TRIP-E study (ACTRN12612000226808) for cross referencing purposes
- •1.Participants randomised in the TRIP-E study and who finished the treatment period with appropriate compliance with diet and study procedures.
- •2.Ability to give informed consent (Participant, parent or person responsible)
- •3.Females of childbearing potential must have a negative serum betahCG at Visit 1 and either abstain or use acceptable contraception for the duration of the trial.
排除标准
- •1.Participants with a severe intellectual handicap
- •2.History of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis or major depression)
- •3.Participants with history of substance abuse, eating disorders or irritable bowel syndrome
- •4.Females who are pregnant or breast feeding
- •5.Participants with disorders affecting medium and short chain fatty acid oxidation.
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