ALS Reversals - Lunasin Regimen

Completed · Phase 2

Conditions studied: ALS (Amyotrophic Lateral Sclerosis)

In brief

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.

Key facts

Study ID

NCT02709330

Run by

Richard Bedlack, M.D., Ph.D.

People needed

60

Starts

2016-04-01

Expected to finish

2017-09-13

Last updated by the study team

2018-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke Medicine / Neurology — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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