ALS Reversals - Lunasin Regimen

NCT02709330 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00063754
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in H3 Histone Acetylation

  Screening/baseline, Month 1

• Percent Agreement Between the Weights Obtained by Patients and Study Coordinator

  Month 1, Month 12

• Enrollment Rate

  Screening/baseline - Month 12

• Retention Rate

  Month 12

• Frequency of ALS Reversals

  Screening/baseline - Month 12

Study Arms (2)

Lunasin regimen

EXPERIMENTAL

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

Historical controls

ACTIVE COMPARATOR

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

Interventions

Lunasin Regimen DRUG

LunaRich X Capsules, Reliv Now, ProVantage

Lunasin regimen

Historical control OTHER

Matched historical controls will be identified from the PatientsLikeMe database.

Historical controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Richard Bedlack, M.D., Ph.D.: lead

Study Sites (1)

Duke Medicine / Neurology

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 30663902 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Historically Controlled Study

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques

Results Point of Contact

• Title: Richard Bedlack, MD, PhD
• Organization: Duke University

richard.bedlack@duke.edu

919-668-2839

Study Officials

• Richard Bedlack, M.D., Ph.D.

  Associate Professor of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 16, 2016
• Study Start: April 1, 2016
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: December 13, 2018
• Results First Posted: December 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)