Study Purpose:
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.Study Status:
Not recruiting
Disease:
ALS (Amyotrophic Lateral Sclerosis)
Study Type:
Interventional
Type of Intervention:
Drug, N/A
Intervention Name:
Lunasin Regimen, Historical control
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Richard Bedlack, M.D., Ph.D., Associate Professor of Neurology
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Duke University
Durham, North Carolina, 27705 United States
Full Study Summary:
The primary hypothesis is that a supplement regimen containing Lunasin (referred to as the Lunasin regimen) can decrease the rate of ALSFRS-S progression by 50% relative to matched historic controls.
ALS is a devastating motor neuron disease that causes rapidly progressive muscle weakness, disability and premature death. In spite of a large number of attempted ALS trials, there are no significant disease-modifying therapies for this condition.
It was recently reported that a patient with a validated diagnosis of ALS, had experienced dramatic objective improvement in speech, swallowing and limb strength while taking a supplement regimen containing Lunasin. Several other patients with ALS have also reported improvement on this Lunasin regiment, though records were not obtainable to validate these.
The Lunasin regimen will consist of:
- LunaRich X Capsules
- Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants'
- Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids'
Dosages will be titrated up to target over the first 6 days. The subject will take the highest tolerated dosing for the remainder of the 12-month study.
There are 3 in-clinic visits which occur at screening/baseline, Month 1 and Month 12. For Months 2-11, participants will make "virtual visits" by measuring their own ALSFRS-R score and weight and will record it in the PatientsLikeMe website. They will also self-report any perceived efficacy, compliance, adverse events and changes in concomitant medications.
ALS is a devastating motor neuron disease that causes rapidly progressive muscle weakness, disability and premature death. In spite of a large number of attempted ALS trials, there are no significant disease-modifying therapies for this condition.
It was recently reported that a patient with a validated diagnosis of ALS, had experienced dramatic objective improvement in speech, swallowing and limb strength while taking a supplement regimen containing Lunasin. Several other patients with ALS have also reported improvement on this Lunasin regiment, though records were not obtainable to validate these.
The Lunasin regimen will consist of:
- LunaRich X Capsules
- Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants'
- Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids'
Dosages will be titrated up to target over the first 6 days. The subject will take the highest tolerated dosing for the remainder of the 12-month study.
There are 3 in-clinic visits which occur at screening/baseline, Month 1 and Month 12. For Months 2-11, participants will make "virtual visits" by measuring their own ALSFRS-R score and weight and will record it in the PatientsLikeMe website. They will also self-report any perceived efficacy, compliance, adverse events and changes in concomitant medications.
Study Sponsor:
Richard Bedlack, M.D., Ph.D.
Participant Duration:
12 months
Estimated Enrollment:
60
Estimated Study Start Date:
04 / 01 / 2016
Estimated Study Completion Date:
09 / 13 / 2017
Posting Last Modified Date:
12 / 13 / 2018
Date Study Added to neals.org:
03 / 16 / 2016
Minimum Age:
18 Years
Maximum Age:
N/A
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.
Duke Medicine / Neurology
Durham, North Carolina
27705
United States