An Open-label, Single-center, 6-month Trial of Theracurmin 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
- 100
- 试验地点
- 1
- 主要终点
- Change in ALSFRS-R Slope
研究概览
简要总结
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.
详细描述
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group. Following informed consent and screening, participants with ALS will take Theracurmin 1 capsule (90mg) twice daily for 6-months. Treatment with the Theracurmin and all study outcome measures and labs are being performed exclusively for research purposes. Collected data includes saliva and stool microbiome sampling, adverse events, concomitant medications, weight and height, Theracurmin treatment evaluations, and Thrive Questionnaires. Participants will be asked to register on the website Patientslikeme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
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.
- •Patient is expected to survive for the duration of the trial.
- •Women must not be pregnant (will have evidence of a negative pregnancy test obtained by local physician within past 7 days or be post-menopausal)
- •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 (those that are part of an active research study).
- •Prior side effects from curcumin or turmeric containing products
- •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.
- •Life expectancy shorter than the duration of the trial.
- •Taking an antiplatelet agent or anticoagulant (due to the theoretically increased risk of bleeding from curcumin products).
研究组 & 干预措施
Open Label Arm
The intervention is twice daily dosage of Theracurmin 90 mg capsules. This same dose was used in a successful trial of patients with mild cognitive impairment. Theracurmin HP capsules containing 90 mg curcumin each that will be taken as one capsule twice daily for 6 months. Each capsule contains 300 mg Theracurmin enhanced bioavailable water-dispersible turmeric rhizome complex providing 30% curcumin (90 mg). The content of Theracurmin HP has been independently certified by NSF International under NSF/ANSI 173.
干预措施: Theracurmin HP (Drug)
结局指标
主要结局
Change in ALSFRS-R Slope
时间窗: Starting at week 4 and then once every 30 days for 6 months
The ALSFRS-R (ALS Functional Rating Scale-Revised) will be determined at all video/telephone visits. ALSFRS-R is a quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Change in ALSFRS-R scores correlate with change in strength over time, and it is closely associated with quality of life measures and predicted survival. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.
次要结局
- Total Number of Adverse Events as Measured by Patient Reporting(up to 6 months)
- Enrollment Rate(up to 6 months)
- Retention as Measured by the Number of Participants Who Completed the 6 Month Study Visit(month 6)
- Number of Participants With ALS Reversal(Month 6)
- Shannon Diversity Index of the Oral Microbiome(Baseline, month 1, month 6)
- Faith's Phylogenetic Diversity of the Oral Microbiome(Baseline, month 1, and month 6)
- Observed Features (Amplicon Sequence Variants, ASV) of the Oral Microbiome(Baseline, month 1, month 6)
- Pielou's Evenness Index of the Oral Microbiome(Baseline, month 1, month 6)
- Shannon Diversity Index of the Stool Microbiome(Baseline, month 1, month 6)
- Faith's Phylogenetic Diversity of the Stool Microbiome(Baseline, month 1, month 6)
- Observed Features (Amplicon Sequence Variants, ASVs) of the Stool Microbiome(Baseline, month 1, month 6)
- Pielou's Evenness Index of the Stool Microbiome(Baseline, month 1, month 6)
研究者
Richard Bedlack, M.D., Ph.D.
Professor of Neurology
Duke University