ALS Reversals - Lunasin Regimen

NCT ID: NCT02709330

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-09-13

Brief 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.

Detailed Description

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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lunasin regimen

The Lunasin regimen consists of:

• LunaRich X Capsules (12 capsules per day)
• Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day)
• Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Group Type: EXPERIMENTAL

Lunasin Regimen

Intervention Type: DRUG

LunaRich X Capsules, Reliv Now, ProVantage

Historical controls

For each enrolled participant, matched historical controls will be identified from the PatientsLikeMe database. Participants will be matched according to their ALSFRS-R progression rate before they start on the Lunasin regimen (estimated by assuming their score was normal at 48 on the date of symptom onset).

Group Type: ACTIVE_COMPARATOR

Historical control

Intervention Type: OTHER

Matched historical controls will be identified from the PatientsLikeMe database.

Interventions

Lunasin Regimen

LunaRich X Capsules, Reliv Now, ProVantage

Intervention Type: DRUG

Historical control

Matched historical controls will be identified from the PatientsLikeMe database.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

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

Associate Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Neurology

Locations

Duke Medicine / Neurology

Durham, North Carolina, United States

Countries

United States

References

Bedlack RS, Wicks P, Vaughan T, Opie A, Blum R, Dios A, Sadri-Vakili G. Lunasin does not slow ALS progression: results of an open-label, single-center, hybrid-virtual 12-month trial. Amyotroph Lateral Scler Frontotemporal Degener. 2019 May;20(3-4):285-293. doi: 10.1080/21678421.2018.1556698. Epub 2019 Jan 21.

Reference Type: DERIVED

PMID: 30663902 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00063754

Identifier Type: -

Identifier Source: org_study_id