烟酰胺/紫檀芪补充剂在 ALS 中的试验：NO-ALS 扩展研究
ALS 烟酰胺/紫檀芪补充剂的随机安慰剂对照试验：NO-ALS 研究。扩展协议
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Bergen、挪威
- Haukeland University Hospital
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Bodø、挪威
- Nordlandssykehuset HF
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Drammen、挪威
- Vestre Viken HF
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Førde、挪威
- Helse Førde HF
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Haugesund、挪威
- Helse Fonna HF
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Kristiansand、挪威
- Sørlandet sykehus
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Lillehammer、挪威
- Sykehuset Innlandet HF
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Lørenskog、挪威
- Akershus University Hospital
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Molde、挪威
- Helse Møre og Romsdal
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Namsos、挪威
- Helse Nord-Trøndelag HF
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Oslo、挪威
- Oslo Univerity Hospital
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Sarpsborg、挪威
- Sykehuset Østfold HF
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Skien、挪威
- Sykehuset i Telemark HF
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Stavanger、挪威
- Stavanger University Hospital
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Tromsø、挪威
- Universitetssykehuset Nord-Norge
-
Trondheim、挪威
- St. Olavs Hospital HF
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Tønsberg、挪威
- Sykehuset i Vestfold HF
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：NO-ALS 扩展研究高剂量 EH301
|
For this study EH301 is defined as Investigational Product(s) (IP). The ALS extension study is an open label study with active treatment of all patients thet have passed through the NO-ALS trial. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adverse events
大体时间：Through study completion, 1 year
|
Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene. |
Through study completion, 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
大体时间：Determined after 12 months of follow-up.
|
ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with ALS. The minimum score is 0 and the maximum score is 48, the higher score the more function is retained. |
Determined after 12 months of follow-up.
|
|
Change in vital capacity
大体时间：Determined after 12 months of follow-up.
|
Vital capacity measured by spirometry. |
Determined after 12 months of follow-up.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival
大体时间：Determined after 12 months of follow-up.
|
Defined as how many are alive or not requiring continuous respiratory ventilation life support. |
Determined after 12 months of follow-up.
|
合作者和调查者
合作者
调查人员
- 首席研究员：Ole-Bjørn Tysnes、Haukeland University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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