Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of patients with sustained disability progression over the treatment period
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Nicotinamide riboside (NR) for treatment of patients with progressive multiple sclerosis.
The main question it aims to answer is:
• Does NR delay disability progression in progressive multiple sclerosis?
Participants will be treated with NR or placebo for 30 months,
详细描述
After being informed about the study and risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry.
At baseline patients who meet the eligibility requirements will be randomised in a double- blinded manner (patient and investigator) in a 1:1 ratio to nicotinamide riboside (1000 mg daily) or placebo (once a day)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of progressive MS (secondary; SPMS or primary; PPMS) according to the 2013 revisions of clinical course of multiple sclerosis and the 2017 revisions of the McDonald criteria.
- •Aged 18-65 years.
- •EDSS 3-6.5
- •Able to perform T25FW test
- •The participant must have documented evidence of disability progression observed during the 24 months before screening.
- •With or without a stable disease modifying therapy during the last three months.
- •Written informed consent for study participation.
排除标准
- •A diagnosis of relapsing MS according to the revisions of the McDonald criteria
- •Neoplastic disease at baseline
- •Previous history of malignant melanoma or breast cancer
- •Stable phase of a progressive disease course
- •Pregnancy or lactating female patients
- •Dementia or other neurodegenerative disorder at baseline visit
- •Comorbidity (psychiatric or somatic) that precludes study participation
- •Use of high dose vitamin B3 supplementation within 30 days of enrolment
- •Genetically confirmed mitochondrial disease or metabolic disorder
结局指标
主要结局
Proportion of patients with sustained disability progression over the treatment period
时间窗: Baseline to month 30
Defined as an increase in either expanded disability status scale (EDSS), timed 25 foot -walk test (T25W) or 9-hole-peg test. EDSS is measured in scores from 0 - 10. The higher the score the less ambulatory ability. Progression is defined as an increase of \>/=1.0 point if baseline EDSS is \</= 5.5 or an increase of \>/=0.5 point if baseline EDSS is \>/= 5.5. Progression in T25WT and 9HPT is defined as an increase of 20% from baseline measures in minutes/seconds.
次要结局
- Time to onset of sustained disability progression over the treatment period(Baseline to month 30)
- To determine the efficacy of NR compared with placebo, as reflected by total volume of T2 lesions on MRI scans of the brain(Baseline to month 24)
- To determine the efficacy of NR compared with placebo, as reflected by 25-footwalk(Baseline to month 30)
- To determine the efficacy of NR compared with placebo, as reflected by formation of lesions(Baseline to month 24)
- To determine the efficacy of NR compared with placebo, as reflected by EDSS(Baseline to month 30)
- To determine the efficacy of NR compared with placebo, as reflected by 9-Hole Peg test(Baseline to month 30)
- Changes in brain atrophy in NR-treated patients with primary progressive multiple sclerosis as compared with placebo(Baseline to month 24)