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).