Overview

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

Status:
Enrolling by invitation
Trial end date:
2022-08-15
Target enrollment:
0
Participant gender:
All
Summary
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Richard Bedlack, M.D., Ph.D.
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).