Trial Outcomes & Findings for ALS Reversals - Lunasin Regimen (NCT NCT02709330)
NCT ID: NCT02709330
Last Updated: 2018-12-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Screening/baseline - 12 months
Results posted on
2018-12-13
Participant Flow
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.
An additional 10 subjects were consented specifically as controls for outcome measure 2 and not included in the treatment group (Lunasin regimen).
Participant milestones
| Measure |
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
Control
Subjects were consented specifically as controls for outcome measure 2 and not included in the treatment (Lunasin regimen) group.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
10
|
|
Overall Study
COMPLETED
|
37
|
10
|
|
Overall Study
NOT COMPLETED
|
13
|
0
|
Reasons for withdrawal
| Measure |
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
Control
Subjects were consented specifically as controls for outcome measure 2 and not included in the treatment (Lunasin regimen) group.
|
|---|---|---|
|
Overall Study
Death
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
ALS Reversals - Lunasin Regimen
Baseline characteristics by cohort
| Measure |
Lunasin Regimen
n=50 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening/baseline - 12 monthsPopulation: 1 participant deleted PLM account; 2 others did not enter ALSFRS-R data.
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.
Outcome measures
| Measure |
Lunasin Regimen
n=47 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
Change in Revised ALS Functional Rating Scale (ALSFRS-R)
|
0.44 points per month
Standard Deviation 1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening/baseline, Month 1Population: 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.
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.
Outcome measures
| Measure |
Lunasin Regimen
n=30 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
n=5 Participants
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
n=4 Participants
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
Change in H3 Histone Acetylation
|
0.993 percentage of baseline
Standard Deviation 0.53
|
1.252 percentage of baseline
Standard Deviation 0.74
|
1.795 percentage of baseline
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Month 1, Month 12Population: Participants with both self-obtained weight and weight obtained by the study coordinator available.
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.
Outcome measures
| Measure |
Lunasin Regimen
n=49 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
Percent Agreement Between the Weights Obtained by Patients and Study Coordinator
Month 1
|
99.47 percentage of agreement
Interval 99.07 to 99.7
|
—
|
—
|
|
Percent Agreement Between the Weights Obtained by Patients and Study Coordinator
Month 12
|
99.05 percentage of agreement
Interval 94.28 to 99.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening/baseline - Month 12Rate of enrollment in reaching the 50 participants required to fill the trial.
Outcome measures
| Measure |
Lunasin Regimen
n=50 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
Enrollment Rate
|
9.1 participants per month
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12Percentage of surviving participants who completed the month 12 visit.
Outcome measures
| Measure |
Lunasin Regimen
n=50 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
Retention Rate
|
84 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening/baseline - Month 12The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months.
Outcome measures
| Measure |
Lunasin Regimen
n=50 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
Frequency of ALS Reversals
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: 2 participants did not provide month 1 scores.
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.
Outcome measures
| Measure |
Lunasin Regimen
n=48 Participants
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
ALS Controls
Individuals with ALS who are not on Lunasin.
|
Healthy Controls
Healthy individuals who are not on Lunasin.
|
|---|---|---|---|
|
ALSFRS-R Accuracy
|
99.39 percentage of accuracy
Interval 98.92 to 99.65
|
—
|
—
|
Adverse Events
Lunasin Regimen
Serious events: 13 serious events
Other events: 45 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Lunasin Regimen
n=50 participants at risk
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
|---|---|
|
Nervous system disorders
Death from ALS progression
|
6.0%
3/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Death from Intracerebral Hemorrhage
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Cardiac disorders
Death from Cardiac Arrest
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Obstipation/Fecal Imaction
|
4.0%
2/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Intracerebral Hemorrhage
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Infections and infestations
PEG Infection
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Subdural Hematoma
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Infections and infestations
C. Diff Infection
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Infections and infestations
Mumps Infection
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
Other adverse events
| Measure |
Lunasin Regimen
n=50 participants at risk
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.
Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
22.0%
11/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Fullness/early satiety
|
16.0%
8/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Decreased Appetite
|
4.0%
2/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Increased ALS progression
|
4.0%
2/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
2/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Skin and subcutaneous tissue disorders
Itching
|
4.0%
2/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon Dioxide Retention
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Musculoskeletal and connective tissue disorders
Hand and Finger Swelling
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Increased Appetite
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Bloating
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Endocrine disorders
Hyperglycemia
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Musculoskeletal and connective tissue disorders
Irritated Hiatal Hernia
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Fall
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Confusion
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Psychiatric disorders
Worsened Anxiety
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Renal and urinary disorders
Prostate Enlargement
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Restless Arm Movements
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Increased Fasciculations
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Infections and infestations
UTI
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Increased Cramps
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Increased Pseudobulbar Affect
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Musculoskeletal and connective tissue disorders
Breast Tenderness
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Nervous system disorders
Heaviness
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Musculoskeletal and connective tissue disorders
Ear Ache
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Weight Gain
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Gastrointestinal disorders
Weight Loss
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
|
Infections and infestations
Influenza Infection
|
2.0%
1/50 • 12 months
Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place