NL-OMON52162已完成2 期
Targeting metabolic flexibility in ALS (MetFlex); safety and tolerability of trimetazidine for the treatment of ALS;An investigator initiated and conducted, multicentre, international, open-label Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND) - MetFlex
niversity of Queensland0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age between 18 and 75 years
- •Signed informed consent prior to the initiation of any study-specific
- •Familial or sporadic ALS/MND, defined as clinically possible, probable,
- •probable laboratory supported or definite as per the El Escorial criteria
- •Relative TRICALS risk score between -6.0 to -2.0 (75% of patients with
- •The use of riluzole will be permitted during the study. Individuals taking
- •riluzole must be on a stable dose for at least 30 days prior to the baseline
- •visit, or stopped taking riluzole at least 30 days prior to the baseline visit.
- •Ability to swallow tablets
- •Able to lie with torso elevated at a 35° angle for 30 minutes without
- •respiratory support
- •Able to give informed consent (as judged by the investigator) and able to
- •comply with all study visits and all study procedures
- •Females must not be able to become pregnant (e.g. post-menopausal, surgically
- •sterile or using highley effective birth control methods) for the duration of
- •Females of child-bearing potential must have a negative serum pregnancy test
- •at screening and baseline and be non-lactating
排除标准
- •History of, or current diagnosis of diabetes or medical condition that
- •impacts whole body energy expenditure (e.g. Hashimoto*s, heart disease)
- •Parkinson*s disease or parkinsonism, tremor, restless-leg syndrome
- •Safety Laboratory Criteria at screening related to significant kidney disease:
- •Creatinine clearance < 50 mL / min (Cockroft-Gault) based on Cystatin C
- •Tracheostomy or non-invasive ventilation (NIV) use > 22 hours per day
- •Contraindication therapy:
- •Allergy for one of the product*s API*s or expedients.
- •Antihypertensive treatment [Trimetazidine may cause hypotension]
- •Evidence of malignant disease
- •Significant neuromuscular disease other than ALS/MND
- •Ongoing disease that may cause neuropathy
- •Pregnancy or breastfeeding
- •Deprivation of freedom by administrative or court order
研究者
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