EUCTR2020-005018-17-NL进行中（未招募）1 期
Targeting metabolic flexibility in ALS (MetFlex); Safety and tolerability of Trimetazidine for the treatment of ALS - MetFlex
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age between 18 and 75 years
- •- Signed informed consent prior to the initiation of any study-specific procedures
- •- 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 ALS/MND)
- •- Metabolic index (defined as measured resting energy expenditure as a % of predicted resting energy expenditure) =110%, averaged over the lead-in period.
- •- 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 the study.
- •- Females of child-bearing potential must have a negative serum pregnancy test at screening and baseline and be non-lactating
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
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
- •- Females actively seeking to become pregnant who are not using an adequate form of contraceptive as detailed in the inclusion criteria.
- •- Deprivation of freedom by administrative or court order
研究者
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