Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 22
- 主要终点
- Survival in ALS-patients with study intervention compared to placebo
研究概览
简要总结
The primary objective of the trial is to investigate the survival time (the time from randomization until death or date of end of the study) compared between control group and experimental group.
This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
- •Disease duration < 36 months
- •Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
- •Age ≥18 years
- •Continuously treated with 100 mg riluzole daily for at least four weeks
- •Capable of thoroughly understanding all information given and giving full informed consent according to GCP
- •Willing to complete a diet questionnaire throughout participation in the study
排除标准
- •Simultaneous participation in another interventional clinical study
- •Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
- •Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
- •Tracheostomy
- •Patients with gastrostomy
- •Pregnancy or breastfeeding
- •Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
- •Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment.
- •Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.
- •Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency.
研究组 & 干预措施
Study Intervention
High caloric fatty diet for drinking (100% lipids, 4.5 kcal/ml) 405 kcal/90 ml/day in addition to daily food intake and standard of care; corresponding to an additional intake of 45 g fat per day
干预措施: Calogen (Dietary Supplement)
Placebo
Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Survival in ALS-patients with study intervention compared to placebo
时间窗: 18 months
次要结局
- Change of total ALS functional rating scale revised (ALSFRS-R)(18 months)
- Change of the slow vital capacity (sVC)(18 months)
- Change of individual quality of life (SEIQoL)(18 months)
- Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)(18 months)
- Time to tracheostomy or death (combined)(18 months)
- Change of Body Mass Index (BMI)(18 months)
研究者
Albert Christian Ludolph, Prof.
Departement of Neurology
University of Ulm