ALS Reversals - Lunasin Regimen

• Status: Completed
• Trial end date: 2017-09-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial utilizing a historical control group. Participants will receive a Lunasin regimen and will be asked to register for an account of PatientsLikeMe website, where after the initial in-clinic visit, they will be asked to enter specific data.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

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.

• 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.

• Prior side effects from Lunasin.

• Known soy allergy.

• 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.