Clinical trial NCT02709330: ALS Reversals - Lunasin Regimen
Official title: An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Revised ALS Functional Rating Scale (ALSFRS-R)
timeFrame: Screening/baseline - 12 months
Secondary outcomes:
measure: Change in H3 Histone Acetylation
timeFrame: Screening/baseline, Month 1
measure: Percent Agreement Between the Weights Obtained by Patients and Study Coordinator
timeFrame: Month 1, Month 12
measure: Enrollment Rate
timeFrame: Screening/baseline - Month 12
measure: Retention Rate
timeFrame: Month 12
measure: Frequency of ALS Reversals
timeFrame: Screening/baseline - Month 12
measure: ALSFRS-R Accuracy
timeFrame: Month 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medicine / Neurology
state: North Carolina
Study officials:
affiliation: Associate Professor of Neurology
name: Richard Bedlack, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.