An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Revised ALS Functional Rating Scale (ALSFRS-R)
研究概览
简要总结
This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial utilizing a historical control group. Participants will receive a Lunasin regimen and will be asked to register for an account of PatientsLikeMe website, where after the initial in-clinic visit, they will be asked to enter specific data.
详细描述
The primary hypothesis is that a supplement regimen containing Lunasin (referred to as the Lunasin regimen) can decrease the rate of ALSFRS-S progression by 50% relative to matched historic controls.
ALS is a devastating motor neuron disease that causes rapidly progressive muscle weakness, disability and premature death. In spite of a large number of attempted ALS trials, there are no significant disease-modifying therapies for this condition.
It was recently reported that a patient with a validated diagnosis of ALS, had experienced dramatic objective improvement in speech, swallowing and limb strength while taking a supplement regimen containing Lunasin. Several other patients with ALS have also reported improvement on this Lunasin regiment, though records were not obtainable to validate these.
The Lunasin regimen will consist of:
- LunaRich X Capsules
- Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants'
- Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids'
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female, aged at least 18 years.
- •Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
- •Patient is able to understand and express informed consent (in the opinion of the site investigator).
- •Patient has access to the Internet on a desktop computer, laptop, or tablet and has a working email address.
- •Patient or caregiver is willing and able to use a computer and enter data on a secure website.
- •Patient is able to read and write English.
- •Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
排除标准
- •Patient is taking other experimental treatments for ALS.
- •Prior side effects from Lunasin.
- •Known soy allergy.
- •Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study.
- •Pregnant women or women currently breastfeeding.
研究组 & 干预措施
Lunasin regimen
The Lunasin regimen consists of:
- LunaRich X Capsules (12 capsules per day)
- Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day)
- Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day)
It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.
干预措施: Lunasin Regimen (Drug)
Historical controls
For each enrolled participant, matched historical controls will be identified from the PatientsLikeMe database. Participants will be matched according to their ALSFRS-R progression rate before they start on the Lunasin regimen (estimated by assuming their score was normal at 48 on the date of symptom onset).
干预措施: Historical control (Other)
结局指标
主要结局
Change in Revised ALS Functional Rating Scale (ALSFRS-R)
时间窗: Screening/baseline - 12 months
ALSFRS-R is a quickly administered (five minute) ordinal rating scale used to determine patient's assessment of their capability and independence in 13 functional activities. All 13 activities are relevant in ALS. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability, with a total score of 52 points. Reported is the rate of change in total points per month.
次要结局
- Percent Agreement Between the Weights Obtained by Patients and Study Coordinator(Month 1, Month 12)
- Enrollment Rate(Screening/baseline - Month 12)
- Retention Rate(Month 12)
- Frequency of ALS Reversals(Screening/baseline - Month 12)
- ALSFRS-R Accuracy(Month 1)
- Change in H3 Histone Acetylation(Screening/baseline, Month 1)
研究者
Richard Bedlack, M.D., Ph.D.
Associate Professor of Neurology
Duke University