Clinical trial NCT04499963: Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: An Open-label, Single-center, 6-month Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a 6-month, widely inclusive, largely remote/virtual, single-center, open-label pilot trial utilizing a historical control group.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in ALSFRS-R Slope
timeFrame: Starting at week 4 and then once every 30 days for 6 months
Secondary outcomes:
measure: Number of Participants With ALS Reversal
timeFrame: Month 6
measure: Total Number of Adverse Events as Measured by Patient Reporting
timeFrame: up to 6 months
measure: Enrollment Rate
timeFrame: up to 6 months
measure: Retention as Measured by the Number of Participants Who Completed the 6 Month Study Visit
timeFrame: month 6
measure: Shannon Diversity Index of the Oral Microbiome
timeFrame: Baseline, month 1, month 6
measure: Faith's Phylogenetic Diversity of the Oral Microbiome
timeFrame: Baseline, month 1, and month 6
measure: Observed Features (Amplicon Sequence Variants, ASV) of the Oral Microbiome
timeFrame: Baseline, month 1, month 6
measure: Pielou's Evenness Index of the Oral Microbiome
timeFrame: Baseline, month 1, month 6
measure: Shannon Diversity Index of the Stool Microbiome
timeFrame: Baseline, month 1, month 6
measure: Faith's Phylogenetic Diversity of the Stool Microbiome
timeFrame: Baseline, month 1, month 6
measure: Observed Features (Amplicon Sequence Variants, ASVs) of the Stool Microbiome
timeFrame: Baseline, month 1, month 6
measure: Pielou's Evenness Index of the Stool Microbiome
timeFrame: Baseline, month 1, month 6
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard Bedlack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: