Study Purpose:
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Theracurmin HP
Placebo:
No
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Richard Bedlack, MD, PhD, Duke University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Duke University Medical Center
Durham, North Carolina, 27705 United States
Full Study Summary:
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 Sponsor:
Richard Bedlack, M.D., Ph.D.
Participant Duration:
6 months
Estimated Enrollment:
68
Estimated Study Start Date:
08 / 28 / 2020
Estimated Study Completion Date:
08 / 30 / 2022
Posting Last Modified Date:
09 / 27 / 2022
Date Study Added to neals.org:
08 / 05 / 2020
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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).
Duke University Medical Center
Durham, North Carolina
27705
United States