Status:
COMPLETED
Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Richard Bedlack, M.D., Ph.D.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04499963
Start Date
August 28 2020
End Date
August 30 2022
Last Update
September 28 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705