A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The mean survival from the time of diagnosis is 2.5 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK (Norwegian kroner) per year.
Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to Nicotinamide Adenine Dinucleotide (NAD) can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilbene will stimulate sirtuins.
The investigators want to study whether combination therapy with NR and Pterostilbene can inhibit neurodegeneration in ALS and thereby delay disease development, increase survival and improve quality of life in ALS.
In the NO-ALS extension study the investigators will follow the patients who completed the original NO-ALS study. Objectives are to evaluate adverse events and give patients possibility of compassionate use, and secondarily to see if the combination of NR and pterostilbene (EH301) will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfilled the criteria for the NO-ALS study and have completed the study will be proposed inclusion in the NO-ALS extension study protocol. Patients from both arm 1 and arm 2 in the NO-ALS study will be allowed inclusion in the prolongation study
排除标准
- •Individuals will be excluded if any of the following exclusion criteria apply:
- •Dementia, fronto temporal dementia (FTD) or other neurodegenerative disorder interfering with compliance.
- •Metabolic, neoplastic, or other physically or mentally debilitating disorder.
- •Patients who become tracheostomized as part of the treatment of ALS.
- •Patients with short expected survival at the discretion of the investigator. Such cases cannot be expected to follow protocol procedures.
- •Use of Vit B3 or blue berry extracts outside the study
研究组 & 干预措施
NO-ALS Extension Study High Dose EH301
干预措施: EH301 (Nicotinamide Riboside/Pterostilbene) (Dietary Supplement)
结局指标
主要结局
Incidence of adverse events
时间窗: Through study completion, 1 year
Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.
次要结局
- Change in vital capacity(Determined after 12 months of follow-up.)
- Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)(Determined after 12 months of follow-up.)