NL-OMON49029
已完成
2 期
A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation. - KHENERGYZE
Khondrion B.V.0 个研究点目标入组 9 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Khondrion B.V.
- 入组人数
- 9
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Trial is onging in other countries
研究者
入排标准
入选标准
- •1\. Males and females aged 18 years or older at screening.
- •2\. Ability and willingness to provide written Informed Consent prior to
- •screening evaluations.
- •3\. Confirmed mitochondrial DNA tRNALeu(UUR) m.3243A\>G mutation (heteroplasmy \>\=
- •20%, urinary epithelial cells).
- •4\. Positive NMDAS score \>10 at Screening.
- •5\. Three or more clinical features, with no other causative unifying
- •diagnosis, found to commonly occur in subjects with a m.3243A\>G mutation:
- •\- Deafness
- •\- Developmental delay
排除标准
- •1\. Surgery of gastro\-intestinal tract that might interfere with absorption.
- •2\. Treatment with an investigational product within 3 months or 5 times the
- •half\-life of the investigational product (whichever is longer) prior to the
- •first dose of the study medication.
- •3\. Documented history of ventricular tachycardia (HR\>110 beats/min).
- •4\. History of acute heart failure, (family) history of unexplained syncope or
- •congenital long and short QT syndrome or sudden death.
- •5\. Clinically relevant abnormal laboratory, vital signs or physical or mental
- •a) Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) \> 3 x
- •upper limit of normal (ULN), or bilirubin \> 3 x ULN at screening. If a patient
结局指标
主要结局
未指定
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