ALS Reversals - Lunasin Regimen
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|ClinicalTrials.gov Identifier: NCT02709330|
Recruitment Status : Completed
First Posted : March 16, 2016
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|ALS (Amyotrophic Lateral Sclerosis)||Drug: Lunasin Regimen Other: Historical control||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Lunasin regimen
The Lunasin regimen consists of:
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.
- 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.
- 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.
- 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.
- Enrollment Rate [ Time Frame: Screening/baseline - Month 12 ]Rate of enrollment in reaching the 50 participants required to fill the trial.
- Retention Rate [ Time Frame: Month 12 ]Percentage of surviving participants who completed the month 12 visit.
- 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.
- 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.
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
|United States, North Carolina|
|Duke Medicine / Neurology|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Richard Bedlack, M.D., Ph.D.||Associate Professor of Neurology|