ALS Reversals - Lunasin Regimen

An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)

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 Overview

• Status: Completed
• Conditions: ALS (Amyotrophic Lateral Sclerosis)
• Intervention / Treatment: Drug: Lunasin Regimen; Other: Historical control

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Medicine / Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lunasin Regimen; LunaRich X Capsules, Reliv Now, ProVantage
Active Comparator: 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).	Other: Historical control; Matched historical controls will be identified from the PatientsLikeMe database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Revised ALS Functional Rating Scale (ALSFRS-R)	ALSFRS-R is a quickly administered (five minute) ordinal rating scale used to determine patient's assessment of their capability and independence in 13 functional activities. All 13 activities are relevant in ALS. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability, with a total score of 52 points. Reported is the rate of change in total points per month.	Screening/baseline - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in H3 Histone Acetylation	Participants, ALS controls (not on Lunasin) and healthy controls (not on Lunasin) had blood drawn at baseline and 1 month time points. Histones were extracted from blood cells. Western blots were used to look at specific histone acetylation patterns that Lunasin had reportedly altered in cell cultures (H3K9K14ac2 and H4K5K8K12K16). Integrated density values for AcH3 protein bands were normalized for total H3. Percent H3 values for the 1 month time point were normalized to that of the baseline visit. Results were analyzed by one-way ANOVA.	Screening/baseline, Month 1
Percent Agreement Between the Weights Obtained by Patients and Study Coordinator	To confirm that participants can accurately measure their own weight, even as they become more disabled by ALS, the investigators will compare the participant-generated weight with the weight obtained by the study coordinator at the Month 1 and Month 12 visits. A simple description of the accuracy (percent agreement between the weights) will be used.	Month 1, Month 12
Enrollment Rate	Rate of enrollment in reaching the 50 participants required to fill the trial.	Screening/baseline - Month 12
Retention Rate	Percentage of surviving participants who completed the month 12 visit.	Month 12
Frequency of ALS Reversals	The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months.	Screening/baseline - Month 12
ALSFRS-R Accuracy	To confirm that participants can accurately measure their own ALS Functional Rating Scale (Revised, ALSFRS-R), the investigators will compare the ALSFRS-R obtained by the coordinator with that obtained by the participants themselves at the Month 1 Visit. Correlational analysis between these 2 scores will be performed with Spearman's rho.	Month 1

Collaborators and Investigators

• Sponsor: Richard Bedlack, M.D., Ph.D.
• Investigators: Principal Investigator: Richard Bedlack, M.D., Ph.D., Associate Professor of Neurology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): September 13, 2017
• Study Completion (Actual): September 13, 2017

Study Registration Dates

• First Submitted: March 5, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: Pro00063754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Participants will be assigned a global unique ID number (GUID), which will allow de-identified data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No