Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)

Richard Bedlack, M.D., Ph.D.100 enrolled

Overview

This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Theracurmin HPDRUG

The intervention is based on the twice daily dosage of Theracurmin 90 mg capsules used in a trial of patients with mild cognitive impairment

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in ALSFRS-R Slope

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.

Time frame: Starting at week 4 and then once every 30 days for 6 months

Secondary Outcomes

Number of Participants With ALS Reversal

Number of participants who have an ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) score that improves by 4 points or more over 6 months. The ALSFRS-R is 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.

Time frame: Month 6

Total Number of Adverse Events as Measured by Patient Reporting

Adverse and serious adverse events will be recorded throughout the study.

Time frame: up to 6 months

Enrollment Rate

The number of participants enrolled divided by the number of months it took to enroll them.

Time frame: up to 6 months

Retention as Measured by the Number of Participants Who Completed the 6 Month Study Visit

Data from ClinicalTrials.gov

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The percentage of enrolled participants who completed the 6 month study visit.

Shannon Diversity Index of the Oral Microbiome

Comparing the changes in the saliva microbiome over time in patients with ALS on Theracurmin to the changes observed in untreated healthy controls. Data will be compared within subjects with ALS to assess possible changes over the length of the study and identify microbial correlates of disease progression. The Shannon diversity index takes into account the number of species living in a habitat (richness) and their relative abundance (evenness). The minimum value is 0, which indicates no diversity (only one species is found). There is no upper limit to the index; the maximum value occurs when all species have the same number of individuals. Baseline was compared to post-treatment samples from months 1 and 6 analyzed together.