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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lunasin regimen | Experimental | 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lunasin Regimen | Drug | LunaRich X Capsules, Reliv Now, ProVantage |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bedlack, M.D., Ph.D. | Associate Professor of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medicine / Neurology | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30663902 | Derived | 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. |
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Participants will be assigned a global unique ID number (GUID), which will allow de-identified data sharing.
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An additional 10 subjects were consented specifically as controls for outcome measure 2 and not included in the treatment group (Lunasin regimen).
Subjects were recruited from the clinic patient population and outside advertisements and postings. Recruitment began 3/28/2016 and ended 9/14/16 once 50 subjects had been enrolled. Study visits were conducted at the Duke ALS clinic and via phone contacts.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage |
| FG001 | Control | Subjects were consented specifically as controls for outcome measure 2 and not included in the treatment (Lunasin regimen) group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 1 participant deleted PLM account; 2 others did not enter ALSFRS-R data. | Posted | Mean | Standard Deviation | points per month | Screening/baseline - 12 months |
|
12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death from ALS progression | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Bedlack, MD, PhD | Duke University | 919-668-2839 | richard.bedlack@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2015 | Jul 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D065386 | Historically Controlled Study |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| Historical control |
| Other |
Matched historical controls will be identified from the PatientsLikeMe database. |
|
| 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 |
| Physician Decision |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | Lunasin regimen: 20 of 50 enrolled participants did not have sufficient sample. Five ALS control subjects (not on Lunasin) and five healthy control subjects (not on Lunasin) were also consented specifically for this analysis. One of the healthy controls did not have sufficient sample. | Posted | Mean | Standard Deviation | percentage of baseline | Screening/baseline, Month 1 |
|
|
|
|
| Secondary | 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. | Participants with both self-obtained weight and weight obtained by the study coordinator available. | Posted | Number | 95% Confidence Interval | percentage of agreement | Month 1, Month 12 |
|
|
|
|
| Secondary | Enrollment Rate | Rate of enrollment in reaching the 50 participants required to fill the trial. | Posted | Number | participants per month | Screening/baseline - Month 12 |
|
|
|
| Secondary | Retention Rate | Percentage of surviving participants who completed the month 12 visit. | Posted | Number | percentage of participants | Month 12 |
|
|
|
| Secondary | Frequency of ALS Reversals | The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months. | Posted | Number | percentage of participants | Screening/baseline - Month 12 |
|
|
|
| Secondary | 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. | 2 participants did not provide month 1 scores. | Posted | Mean | 95% Confidence Interval | percentage of accuracy | Month 1 |
|
|
|
|
| 5 |
| 50 |
| 13 |
| 50 |
| 45 |
| 50 |
| Death from Intracerebral Hemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Death from Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
|
| Obstipation/Fecal Imaction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intracerebral Hemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| PEG Infection | Infections and infestations | Non-systematic Assessment |
|
| Subdural Hematoma | Nervous system disorders | Non-systematic Assessment |
|
| C. Diff Infection | Infections and infestations | Non-systematic Assessment |
|
| Mumps Infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Fullness/early satiety | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Decreased Appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased ALS progression | Nervous system disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Carbon Dioxide Retention | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hand and Finger Swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Increased Appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
|
| Irritated Hiatal Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall | Nervous system disorders | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | Non-systematic Assessment |
|
| Worsened Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Prostate Enlargement | Renal and urinary disorders | Non-systematic Assessment |
|
| Restless Arm Movements | Nervous system disorders | Non-systematic Assessment |
|
| Increased Fasciculations | Nervous system disorders | Non-systematic Assessment |
|
| UTI | Infections and infestations | Non-systematic Assessment |
|
| Increased Cramps | Nervous system disorders | Non-systematic Assessment |
|
| Increased Pseudobulbar Affect | Nervous system disorders | Non-systematic Assessment |
|
| Breast Tenderness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heaviness | Nervous system disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Ear Ache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Weight Gain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight Loss | Gastrointestinal disorders | Non-systematic Assessment |
|
| Influenza Infection | Infections and infestations | Non-systematic Assessment |
|
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|