Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ALS Reversals - Lunasin Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02709330
Recruitment Status : Completed
First Posted : March 16, 2016
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Bedlack, M.D., Ph.D., Duke University

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.

Condition or disease Intervention/treatment Phase
ALS (Amyotrophic Lateral Sclerosis) Drug: Lunasin Regimen Other: Historical control Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : April 2016
Actual Primary Completion Date : September 13, 2017
Actual Study Completion Date : September 13, 2017


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.




Primary Outcome Measures :
  1. Change in Revised ALS Functional Rating Scale (ALSFRS-R) [ Time Frame: Screening/baseline - 12 months ]
    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.


Secondary Outcome Measures :
  1. Change in H3 Histone Acetylation [ Time Frame: Screening/baseline, Month 1 ]
    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.

  2. Percent Agreement Between the Weights Obtained by Patients and Study Coordinator [ Time Frame: Month 1, Month 12 ]
    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.

  3. Enrollment Rate [ Time Frame: Screening/baseline - Month 12 ]
    Rate of enrollment in reaching the 50 participants required to fill the trial.

  4. Retention Rate [ Time Frame: Month 12 ]
    Percentage of surviving participants who completed the month 12 visit.

  5. Frequency of ALS Reversals [ Time Frame: Screening/baseline - Month 12 ]
    The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months.

  6. ALSFRS-R Accuracy [ Time Frame: Month 1 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709330


Locations
Layout table for location information
United States, North Carolina
Duke Medicine / Neurology
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Richard Bedlack, M.D., Ph.D.
Investigators
Layout table for investigator information
Principal Investigator: Richard Bedlack, M.D., Ph.D. Associate Professor of Neurology
  Study Documents (Full-Text)

Documents provided by Richard Bedlack, M.D., Ph.D., Duke University:

Layout table for additonal information
Responsible Party: Richard Bedlack, M.D., Ph.D., Associate Professor of Neurology, Duke University
ClinicalTrials.gov Identifier: NCT02709330     History of Changes
Other Study ID Numbers: Pro00063754
First Posted: March 16, 2016    Key Record Dates
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be assigned a global unique ID number (GUID), which will allow de-identified data sharing.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases