Trial Outcomes & Findings for Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis (NCT NCT02447952)

Last Updated: 2018-12-26

Results Overview

Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent \[Active + lying + sedentary not lying\] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was \<=1.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Up to Week 48

Results posted on

2018-12-26

Participant Flow

This is an exploratory, non-controlled, non-drug study in participants with amyotrophic lateral sclerosis (ALS). The study enrolled participants using two sites based in the United Kingdom

Of total 25 screened participants, 5 participants were included in pilot phase of which 2 completed and entered core study phase with other 23 participants.

Participant milestones

Participant milestones
Measure	Mega Faros Device + Fast Fix In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Study STARTED	25
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Mega Faros Device + Fast Fix In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Study Adverse Event	2
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Age, Continuous	53.1 Years STANDARD_DEVIATION 9.93 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 48

Population: Full Analysis Set included all participants with at least one post Baseline measure for the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and at least one physical activity/movement measure.

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Duration of Day Time Wear Time of the Device Week 0, Day 1, n=24	718.536 Minutes Standard Deviation 190.4933
Duration of Day Time Wear Time of the Device Week4, Day 2, n=22	778.636 Minutes Standard Deviation 169.6978
Duration of Day Time Wear Time of the Device Week4, Day 3, n=21	605.334 Minutes Standard Deviation 319.5373
Duration of Day Time Wear Time of the Device Week4, Day 4, n=9	207.092 Minutes Standard Deviation 293.8405
Duration of Day Time Wear Time of the Device Week4, Day 5, n=5	137.600 Minutes Standard Deviation 300.5371
Duration of Day Time Wear Time of the Device Week4, Day 6, n=1	657.500 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week8, Day 1, n=19	647.735 Minutes Standard Deviation 291.5468
Duration of Day Time Wear Time of the Device Week20,Day 4, n=4	172.793 Minutes Standard Deviation 345.3584
Duration of Day Time Wear Time of the Device Week28,Day 3, n=9	588.464 Minutes Standard Deviation 359.3972
Duration of Day Time Wear Time of the Device Week28,Day 4, n=6	357.220 Minutes Standard Deviation 363.2050
Duration of Day Time Wear Time of the Device Week40,Day 1, n=12	722.708 Minutes Standard Deviation 239.1189
Duration of Day Time Wear Time of the Device Week40,Day 2, n=12	618.555 Minutes Standard Deviation 326.7927
Duration of Day Time Wear Time of the Device Week40,Day 5, n=1	823.500 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week44,Day 5, n=1	146.660 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week48,Day 2, n=13	692.474 Minutes Standard Deviation 251.7305
Duration of Day Time Wear Time of the Device Week 0, Day 2, n=24	730.882 Minutes Standard Deviation 216.3616
Duration of Day Time Wear Time of the Device Week 0, Day 3, n=23	653.980 Minutes Standard Deviation 241.0427
Duration of Day Time Wear Time of the Device Week 0, Day 4, n=12	207.263 Minutes Standard Deviation 275.7507
Duration of Day Time Wear Time of the Device Week 0, Day 5, n=2	342.830 Minutes Standard Deviation 240.4163
Duration of Day Time Wear Time of the Device Week4, Day 1, n=22	762.680 Minutes Standard Deviation 228.5267
Duration of Day Time Wear Time of the Device Week4, Day 7, n=1	820.660 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week4, Day 8, n=1	34.000 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week8, Day 2, n=17	744.028 Minutes Standard Deviation 158.3890
Duration of Day Time Wear Time of the Device Week8, Day 3, n=17	581.939 Minutes Standard Deviation 297.5053
Duration of Day Time Wear Time of the Device Week8, Day 4, n=8	94.709 Minutes Standard Deviation 126.7088
Duration of Day Time Wear Time of the Device Week12,Day 1, n=16	552.668 Minutes Standard Deviation 315.5227
Duration of Day Time Wear Time of the Device Week12,Day 2, n=16	801.697 Minutes Standard Deviation 170.8600
Duration of Day Time Wear Time of the Device Week12,Day 3, n=15	563.311 Minutes Standard Deviation 298.3566
Duration of Day Time Wear Time of the Device Week12,Day 4, n=7	425.336 Minutes Standard Deviation 266.8420
Duration of Day Time Wear Time of the Device Week12,Day 5, n=1	858.660 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week16,Day 1, n=13	759.399 Minutes Standard Deviation 129.2502
Duration of Day Time Wear Time of the Device Week16,Day 2, n=13	812.345 Minutes Standard Deviation 200.5683
Duration of Day Time Wear Time of the Device Week16,Day 3, n=12	631.484 Minutes Standard Deviation 296.3050
Duration of Day Time Wear Time of the Device Week16,Day 4, n=6	254.500 Minutes Standard Deviation 336.6649
Duration of Day Time Wear Time of the Device Week20,Day 1, n=14	774.049 Minutes Standard Deviation 240.7234
Duration of Day Time Wear Time of the Device Week20,Day 2, n=13	648.268 Minutes Standard Deviation 291.9654
Duration of Day Time Wear Time of the Device Week20,Day 3, n=12	615.277 Minutes Standard Deviation 239.5376
Duration of Day Time Wear Time of the Device Week24,Day 1, n=14	505.976 Minutes Standard Deviation 296.3016
Duration of Day Time Wear Time of the Device Week24,Day 2, n=12	617.599 Minutes Standard Deviation 299.5749
Duration of Day Time Wear Time of the Device Week24,Day 3, n=11	481.698 Minutes Standard Deviation 333.5209
Duration of Day Time Wear Time of the Device Week24,Day 4, n=8	306.500 Minutes Standard Deviation 303.9026
Duration of Day Time Wear Time of the Device Week24,Day 5, n=2	287.000 Minutes Standard Deviation 184.7953
Duration of Day Time Wear Time of the Device Week28,Day 1, n=10	690.898 Minutes Standard Deviation 178.9577
Duration of Day Time Wear Time of the Device Week28,Day 2, n=10	722.551 Minutes Standard Deviation 248.5576
Duration of Day Time Wear Time of the Device Week32,Day 1, n=12	575.303 Minutes Standard Deviation 322.1123
Duration of Day Time Wear Time of the Device Week32,Day 2, n=10	592.866 Minutes Standard Deviation 345.4597
Duration of Day Time Wear Time of the Device Week32,Day 3, n=9	599.778 Minutes Standard Deviation 351.8631
Duration of Day Time Wear Time of the Device Week32,Day 4, n=1	32.000 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week36,Day 1, n=12	510.209 Minutes Standard Deviation 381.7060
Duration of Day Time Wear Time of the Device Week36,Day 2, n=9	507.872 Minutes Standard Deviation 397.7501
Duration of Day Time Wear Time of the Device Week36,Day 3, n=6	465.583 Minutes Standard Deviation 340.8965
Duration of Day Time Wear Time of the Device Week36,Day 4, n=4	387.750 Minutes Standard Deviation 424.1863
Duration of Day Time Wear Time of the Device Week36,Day 5, n=2	516.250 Minutes Standard Deviation 454.3161
Duration of Day Time Wear Time of the Device Week36,Day 6, n=1	171.840 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week40,Day 3, n=11	601.665 Minutes Standard Deviation 312.9329
Duration of Day Time Wear Time of the Device Week40,Day 4, n=7	290.857 Minutes Standard Deviation 404.5156
Duration of Day Time Wear Time of the Device Week40,Day 6, n=1	444.830 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Day Time Wear Time of the Device Week44,Day 1, n=12	746.278 Minutes Standard Deviation 258.7132
Duration of Day Time Wear Time of the Device Week44,Day 2, n=11	646.452 Minutes Standard Deviation 295.5684
Duration of Day Time Wear Time of the Device Week44,Day 3, n=10	476.783 Minutes Standard Deviation 355.1196
Duration of Day Time Wear Time of the Device Week44,Day 4, n=4	178.460 Minutes Standard Deviation 308.3123
Duration of Day Time Wear Time of the Device Week48,Day 1, n=13	779.438 Minutes Standard Deviation 120.7527
Duration of Day Time Wear Time of the Device Week48,Day 3, n=10	622.015 Minutes Standard Deviation 243.5040
Duration of Day Time Wear Time of the Device Week48,Day 4, n=5	630.000 Minutes Standard Deviation 380.2256

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent \[Active + day time lying + day time "sedentary not lying"\] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Duration of Night Time Wear Time of the Device Week48,Day 3, n=10	299.985 Minutes Standard Deviation 146.9104
Duration of Night Time Wear Time of the Device Week48,Day 4, n=5	81.400 Minutes Standard Deviation 182.0159
Duration of Night Time Wear Time of the Device Week8, Day 3, n=17	526.825 Minutes Standard Deviation 207.6252
Duration of Night Time Wear Time of the Device Week8, Day 4, n=8	30.041 Minutes Standard Deviation 84.9695
Duration of Night Time Wear Time of the Device Week12,Day 1, n=16	255.708 Minutes Standard Deviation 250.9718
Duration of Night Time Wear Time of the Device Week12,Day 2, n=16	418.489 Minutes Standard Deviation 149.6411
Duration of Night Time Wear Time of the Device Week16,Day 4, n=6	96.000 Minutes Standard Deviation 220.5519
Duration of Night Time Wear Time of the Device Week20,Day 1, n=14	445.811 Minutes Standard Deviation 170.4490
Duration of Night Time Wear Time of the Device Week20,Day 2, n=13	452.345 Minutes Standard Deviation 203.3159
Duration of Night Time Wear Time of the Device Week20,Day 4, n=4	148.458 Minutes Standard Deviation 172.2844
Duration of Night Time Wear Time of the Device Week24,Day 1, n=14	254.095 Minutes Standard Deviation 261.1246
Duration of Night Time Wear Time of the Device Week24,Day 2, n=12	398.068 Minutes Standard Deviation 199.7096
Duration of Night Time Wear Time of the Device Week24,Day 3, n=11	374.121 Minutes Standard Deviation 214.6214
Duration of Night Time Wear Time of the Device Week24,Day 4, n=8	291.376 Minutes Standard Deviation 277.4058
Duration of Night Time Wear Time of the Device Week28,Day 1, n=10	497.701 Minutes Standard Deviation 242.6652
Duration of Night Time Wear Time of the Device Week32,Day 2, n=10	460.233 Minutes Standard Deviation 209.0824
Duration of Night Time Wear Time of the Device Week32,Day 3, n=9	433.778 Minutes Standard Deviation 256.9437
Duration of Night Time Wear Time of the Device Week32,Day 4, n=1	0.000 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week36,Day 1, n=12	189.124 Minutes Standard Deviation 199.2290
Duration of Night Time Wear Time of the Device Week36,Day 2, n=9	263.352 Minutes Standard Deviation 236.3438
Duration of Night Time Wear Time of the Device Week36,Day 3, n=6	380.748 Minutes Standard Deviation 298.7767
Duration of Night Time Wear Time of the Device Week40,Day 3, n=11	419.334 Minutes Standard Deviation 215.0470
Duration of Night Time Wear Time of the Device Week48,Day 1, n=13	439.486 Minutes Standard Deviation 153.3470
Duration of Night Time Wear Time of the Device Week36,Day 4, n=4	358.503 Minutes Standard Deviation 280.5689
Duration of Night Time Wear Time of the Device Week36,Day 5, n=2	201.250 Minutes Standard Deviation 284.6105
Duration of Night Time Wear Time of the Device Week36,Day 6, n=1	505.170 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week40,Day 1, n=12	375.043 Minutes Standard Deviation 192.0867
Duration of Night Time Wear Time of the Device Week44,Day 5, n=1	277.330 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week48,Day 2, n=13	381.988 Minutes Standard Deviation 192.9540
Duration of Night Time Wear Time of the Device Week40,Day 2, n=12	442.528 Minutes Standard Deviation 179.2818
Duration of Night Time Wear Time of the Device Week40,Day 4, n=7	121.573 Minutes Standard Deviation 172.7203
Duration of Night Time Wear Time of the Device Week40,Day 5, n=1	522.500 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week40,Day 6, n=1	163.170 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week44,Day 1, n=12	393.140 Minutes Standard Deviation 192.6969
Duration of Night Time Wear Time of the Device Week44,Day 2, n=11	362.275 Minutes Standard Deviation 208.9128
Duration of Night Time Wear Time of the Device Week44,Day 3, n=10	382.018 Minutes Standard Deviation 201.1957
Duration of Night Time Wear Time of the Device Week44,Day 4, n=4	111.543 Minutes Standard Deviation 223.0850
Duration of Night Time Wear Time of the Device Week 0, Day 1, n=24	448.174 Minutes Standard Deviation 222.1658
Duration of Night Time Wear Time of the Device Week 0, Day 2, n=24	360.575 Minutes Standard Deviation 212.4216
Duration of Night Time Wear Time of the Device Week 0, Day 3, n=23	482.500 Minutes Standard Deviation 150.8251
Duration of Night Time Wear Time of the Device Week 0, Day 4, n=12	134.570 Minutes Standard Deviation 239.8401
Duration of Night Time Wear Time of the Device Week 0, Day 5, n=2	494.170 Minutes Standard Deviation 57.9828
Duration of Night Time Wear Time of the Device Week4, Day 1, n=22	487.682 Minutes Standard Deviation 189.6054
Duration of Night Time Wear Time of the Device Week4, Day 2, n=22	432.273 Minutes Standard Deviation 209.9463
Duration of Night Time Wear Time of the Device Week4, Day 3, n=21	455.047 Minutes Standard Deviation 194.3802
Duration of Night Time Wear Time of the Device Week4, Day 4, n=9	107.796 Minutes Standard Deviation 205.8403
Duration of Night Time Wear Time of the Device Week4, Day 5, n=5	109.400 Minutes Standard Deviation 241.1904
Duration of Night Time Wear Time of the Device Week4, Day 6, n=1	624.500 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week4, Day 7, n=1	462.340 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week4, Day 8, n=1	0.000 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week8, Day 1, n=19	506.316 Minutes Standard Deviation 184.6635
Duration of Night Time Wear Time of the Device Week8, Day 2, n=17	477.441 Minutes Standard Deviation 206.7924
Duration of Night Time Wear Time of the Device Week12,Day 3, n=15	519.888 Minutes Standard Deviation 63.0517
Duration of Night Time Wear Time of the Device Week12,Day 4, n=7	568.381 Minutes Standard Deviation 150.2560
Duration of Night Time Wear Time of the Device Week12,Day 5, n=1	406.340 Minutes Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.
Duration of Night Time Wear Time of the Device Week16,Day 1, n=13	513.448 Minutes Standard Deviation 78.9644
Duration of Night Time Wear Time of the Device Week16,Day 2, n=13	382.038 Minutes Standard Deviation 185.6318
Duration of Night Time Wear Time of the Device Week16,Day 3, n=12	494.932 Minutes Standard Deviation 196.5556
Duration of Night Time Wear Time of the Device Week20,Day 3, n=12	498.806 Minutes Standard Deviation 138.8339
Duration of Night Time Wear Time of the Device Week24,Day 5, n=2	476.995 Minutes Standard Deviation 1.8880
Duration of Night Time Wear Time of the Device Week28,Day 2, n=10	483.950 Minutes Standard Deviation 195.5384
Duration of Night Time Wear Time of the Device Week28,Day 3, n=9	543.759 Minutes Standard Deviation 270.4945
Duration of Night Time Wear Time of the Device Week28,Day 4, n=6	286.778 Minutes Standard Deviation 327.2635
Duration of Night Time Wear Time of the Device Week32,Day 1, n=12	510.447 Minutes Standard Deviation 218.5192

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Average Time Spent Active Night time, Week 8, n=19	2.375 Minutes Standard Deviation 5.7540
Average Time Spent Active Night time, Week 12, n=16	0.484 Minutes Standard Deviation 0.5404
Average Time Spent Active Night time, Week 16, n=13	0.449 Minutes Standard Deviation 0.4684
Average Time Spent Active Night time, Week 20, n=14	0.418 Minutes Standard Deviation 0.5315
Average Time Spent Active Day time, Week 0, n=24	34.420 Minutes Standard Deviation 29.3837
Average Time Spent Active Day time, Week 4, n=22	32.233 Minutes Standard Deviation 33.1012
Average Time Spent Active Day time, Week 8, n=19	24.319 Minutes Standard Deviation 25.5092
Average Time Spent Active Day time, Week 12, n=16	23.904 Minutes Standard Deviation 17.2952
Average Time Spent Active Day time, Week 40, n=12	14.563 Minutes Standard Deviation 18.7912
Average Time Spent Active Day time, Week 44, n=12	20.210 Minutes Standard Deviation 26.0361
Average Time Spent Active Day time, Week 48, n=13	23.578 Minutes Standard Deviation 29.0419
Average Time Spent Active Night time, Week 0, n=24	1.136 Minutes Standard Deviation 1.5427
Average Time Spent Active Night time, Week 4, n=22	0.570 Minutes Standard Deviation 0.6817
Average Time Spent Active Day time, Week 16, n=13	25.863 Minutes Standard Deviation 23.2673
Average Time Spent Active Day time, Week 20, n=14	18.931 Minutes Standard Deviation 18.3595
Average Time Spent Active Day time, Week 24, n=14	12.137 Minutes Standard Deviation 10.8409
Average Time Spent Active Day time, Week 28, n=10	19.856 Minutes Standard Deviation 29.0562
Average Time Spent Active Day time, Week 32, n=12	11.873 Minutes Standard Deviation 15.0988
Average Time Spent Active Day time, Week 36, n=12	14.118 Minutes Standard Deviation 19.7452
Average Time Spent Active Night time, Week 24, n=14	0.387 Minutes Standard Deviation 0.2715
Average Time Spent Active Night time, Week 28, n=10	1.432 Minutes Standard Deviation 3.0455
Average Time Spent Active Night time, Week 32, n=12	0.668 Minutes Standard Deviation 1.5814
Average Time Spent Active Night time, Week 36, n=12	0.414 Minutes Standard Deviation 0.3682
Average Time Spent Active Night time, Week 40, n=12	0.268 Minutes Standard Deviation 0.3272
Average Time Spent Active Night time, Week 44, n=12	0.390 Minutes Standard Deviation 0.7308
Average Time Spent Active Night time, Week 48, n=13	0.518 Minutes Standard Deviation 0.8014

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Average Time Spent 'Sedentary Not Lying' Day time, Week 44, n=12	440.376 Minutes Standard Deviation 198.2569
Average Time Spent 'Sedentary Not Lying' Day time, Week 48, n=13	509.536 Minutes Standard Deviation 171.1560
Average Time Spent 'Sedentary Not Lying' Night time, Week 0, n=24	15.522 Minutes Standard Deviation 28.5337
Average Time Spent 'Sedentary Not Lying' Day time, Week 0, n=24	523.191 Minutes Standard Deviation 113.3016
Average Time Spent 'Sedentary Not Lying' Day time, Week 4, n=22	524.120 Minutes Standard Deviation 182.7753
Average Time Spent 'Sedentary Not Lying' Day time, Week 8, n=19	428.359 Minutes Standard Deviation 210.1894
Average Time Spent 'Sedentary Not Lying' Day time, Week 12, n=16	509.634 Minutes Standard Deviation 105.3263
Average Time Spent 'Sedentary Not Lying' Day time, Week 16, n=13	561.923 Minutes Standard Deviation 100.3003
Average Time Spent 'Sedentary Not Lying' Day time, Week 20, n=14	489.921 Minutes Standard Deviation 202.2926
Average Time Spent 'Sedentary Not Lying' Day time, Week 24, n=14	376.117 Minutes Standard Deviation 222.6009
Average Time Spent 'Sedentary Not Lying' Day time, Week 28, n=10	472.238 Minutes Standard Deviation 215.7768
Average Time Spent 'Sedentary Not Lying' Day time, Week 32, n=12	420.709 Minutes Standard Deviation 259.0856
Average Time Spent 'Sedentary Not Lying' Day time, Week 36, n=12	376.686 Minutes Standard Deviation 233.1990
Average Time Spent 'Sedentary Not Lying' Day time, Week 40, n=12	465.879 Minutes Standard Deviation 181.5005
Average Time Spent 'Sedentary Not Lying' Night time, Week 4, n=22	10.561 Minutes Standard Deviation 12.5485
Average Time Spent 'Sedentary Not Lying' Night time, Week 8, n=19	8.441 Minutes Standard Deviation 5.8601
Average Time Spent 'Sedentary Not Lying' Night time, Week 12, n=16	7.968 Minutes Standard Deviation 4.8657
Average Time Spent 'Sedentary Not Lying' Night time, Week 16, n=13	8.855 Minutes Standard Deviation 5.1855
Average Time Spent 'Sedentary Not Lying' Night time, Week 20, n=14	9.239 Minutes Standard Deviation 6.9942
Average Time Spent 'Sedentary Not Lying' Night time, Week 24, n=14	7.274 Minutes Standard Deviation 6.5610
Average Time Spent 'Sedentary Not Lying' Night time, Week 28, n=10	17.488 Minutes Standard Deviation 15.1698
Average Time Spent 'Sedentary Not Lying' Night time, Week 32, n=12	12.930 Minutes Standard Deviation 14.8779
Average Time Spent 'Sedentary Not Lying' Night time, Week 36, n=12	3.545 Minutes Standard Deviation 3.5805
Average Time Spent 'Sedentary Not Lying' Night time, Week 40, n=12	8.932 Minutes Standard Deviation 5.0236
Average Time Spent 'Sedentary Not Lying' Night time, Week 44, n=12	6.321 Minutes Standard Deviation 4.5166
Average Time Spent 'Sedentary Not Lying' Night time, Week 48, n=13	7.602 Minutes Standard Deviation 7.4373

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Average Time Spent Lying Night time, Week 4, n=22	384.879 Minutes Standard Deviation 97.8424
Average Time Spent Lying Night time, Week 8, n=19	411.110 Minutes Standard Deviation 157.8820
Average Time Spent Lying Night time, Week 12, n=16	417.943 Minutes Standard Deviation 71.9066
Average Time Spent Lying Night time, Week 16, n=13	413.721 Minutes Standard Deviation 129.3161
Average Time Spent Lying Night time, Week 20, n=14	407.060 Minutes Standard Deviation 175.2092
Average Time Spent Lying Night time, Week 24, n=14	318.155 Minutes Standard Deviation 112.8749
Average Time Spent Lying Night time, Week 36, n=12	217.884 Minutes Standard Deviation 181.3682
Average Time Spent Lying Night time, Week 40, n=12	355.222 Minutes Standard Deviation 104.8680
Average Time Spent Lying Night time, Week 44, n=12	319.022 Minutes Standard Deviation 155.2519
Average Time Spent Lying Day time, Week 0, n=24	79.027 Minutes Standard Deviation 59.8512
Average Time Spent Lying Day time, Week 4, n=22	79.996 Minutes Standard Deviation 67.1924
Average Time Spent Lying Day time, Week 8, n=19	90.324 Minutes Standard Deviation 80.8799
Average Time Spent Lying Day time, Week 12, n=16	82.146 Minutes Standard Deviation 59.7457
Average Time Spent Lying Day time, Week 16, n=13	87.271 Minutes Standard Deviation 75.4731
Average Time Spent Lying Day time, Week 20, n=14	89.648 Minutes Standard Deviation 90.8020
Average Time Spent Lying Day time, Week 24, n=14	82.979 Minutes Standard Deviation 89.4852
Average Time Spent Lying Day time, Week 28, n=10	136.170 Minutes Standard Deviation 127.2225
Average Time Spent Lying Day time, Week 32, n=12	99.760 Minutes Standard Deviation 118.3536
Average Time Spent Lying Day time, Week 36, n=12	50.278 Minutes Standard Deviation 48.7456
Average Time Spent Lying Day time, Week 40, n=12	103.749 Minutes Standard Deviation 133.3234
Average Time Spent Lying Day time, Week 44, n=12	71.757 Minutes Standard Deviation 73.5817
Average Time Spent Lying Day time, Week 48, n=13	141.575 Minutes Standard Deviation 140.1450
Average Time Spent Lying Night time, Week 0, n=24	384.886 Minutes Standard Deviation 135.8136
Average Time Spent Lying Night time, Week 28, n=10	454.137 Minutes Standard Deviation 184.2617
Average Time Spent Lying Night time, Week 32, n=12	412.196 Minutes Standard Deviation 170.4452
Average Time Spent Lying Night time, Week 48, n=13	333.358 Minutes Standard Deviation 154.9236

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Number of minutes spent sedentary \[time spent lying + time spent sedentary not lying\] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Average Time Spent Sedentary. Day time, Week 12, n=16	591.779 Minutes Standard Deviation 118.3797
Average Time Spent Sedentary. Day time, Week 16, n=13	649.195 Minutes Standard Deviation 117.2721
Average Time Spent Sedentary. Day time, Week 20, n=14	579.571 Minutes Standard Deviation 213.9093
Average Time Spent Sedentary. Day time, Week 36, n=12	426.962 Minutes Standard Deviation 250.2390
Average Time Spent Sedentary. Day time, Week 40, n=12	569.629 Minutes Standard Deviation 171.5586
Average Time Spent Sedentary. Day time, Week 44, n=12	512.132 Minutes Standard Deviation 203.0705
Average Time Spent Sedentary. Night time, Week 16, n=13	422.574 Minutes Standard Deviation 132.3307
Average Time Spent Sedentary. Night time, Week 20, n=14	416.299 Minutes Standard Deviation 179.9825
Average Time Spent Sedentary. Night time, Week 24, n=14	325.427 Minutes Standard Deviation 114.9446
Average Time Spent Sedentary. Night time, Week 28, n=10	471.626 Minutes Standard Deviation 196.1417
Average Time Spent Sedentary. Day time, Week 0, n=24	602.219 Minutes Standard Deviation 131.7430
Average Time Spent Sedentary. Day time, Week 4, n=22	604.116 Minutes Standard Deviation 165.0799
Average Time Spent Sedentary. Day time, Week 8, n=19	518.684 Minutes Standard Deviation 234.6306
Average Time Spent Sedentary. Day time, Week 24, n=14	459.096 Minutes Standard Deviation 233.1413
Average Time Spent Sedentary. Day time, Week 28, n=10	608.409 Minutes Standard Deviation 141.5444
Average Time Spent Sedentary. Day time, Week 32, n=12	520.468 Minutes Standard Deviation 285.7109
Average Time Spent Sedentary. Day time, Week 48, n=13	651.109 Minutes Standard Deviation 156.3296
Average Time Spent Sedentary. Night time, Week 0, n=24	400.408 Minutes Standard Deviation 132.3420
Average Time Spent Sedentary. Night time, Week 4, n=22	395.438 Minutes Standard Deviation 100.9179
Average Time Spent Sedentary. Night time, Week 8, n=19	419.549 Minutes Standard Deviation 162.0795
Average Time Spent Sedentary. Night time, Week 12, n=16	425.909 Minutes Standard Deviation 69.7741
Average Time Spent Sedentary. Night time, Week 32, n=12	425.125 Minutes Standard Deviation 178.8053
Average Time Spent Sedentary. Night time, Week 36, n=12	221.430 Minutes Standard Deviation 184.4017
Average Time Spent Sedentary. Night time, Week 40, n=12	364.152 Minutes Standard Deviation 105.2901
Average Time Spent Sedentary. Night time, Week 44, n=12	325.343 Minutes Standard Deviation 156.8669
Average Time Spent Sedentary. Night time, Week 48, n=13	340.960 Minutes Standard Deviation 157.6860

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R	0.178 Ratio

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R	-0.426 Ratio

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R	0.049 Ratio

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R	-0.163 Ratio

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 0, n=23	4.1914 Ratio Standard Deviation 2.35370
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 4, n=21	4.2198 Ratio Standard Deviation 2.88326
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 16, n=12	3.7404 Ratio Standard Deviation 1.99810
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 20, n=12	4.6210 Ratio Standard Deviation 3.40720
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 24, n=12	4.2944 Ratio Standard Deviation 2.43365
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 48, n=11	4.4358 Ratio Standard Deviation 2.56115
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 8, n=15	4.2393 Ratio Standard Deviation 2.50840
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 12, n=15	4.2304 Ratio Standard Deviation 2.13905
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 28, n=10	6.1888 Ratio Standard Deviation 5.64815
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 32, n=10	5.0398 Ratio Standard Deviation 3.64394
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 36, n=9	4.9206 Ratio Standard Deviation 3.44514
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 40, n=11	4.6117 Ratio Standard Deviation 2.81758
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) Week 44, n=11	3.8315 Ratio Standard Deviation 2.29689

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Variance of HRV While Lying (LF/HF) Week 0, n=23	6.3439 Ratio Standard Deviation 6.55782
Variance of HRV While Lying (LF/HF) Week 4, n=21	6.8401 Ratio Standard Deviation 6.49766
Variance of HRV While Lying (LF/HF) Week 8, n=15	5.3481 Ratio Standard Deviation 4.86394
Variance of HRV While Lying (LF/HF) Week 12, n=15	11.4190 Ratio Standard Deviation 11.42238
Variance of HRV While Lying (LF/HF) Week 16, n=12	16.1974 Ratio Standard Deviation 20.59606
Variance of HRV While Lying (LF/HF) Week 20, n=12	10.2248 Ratio Standard Deviation 13.69276
Variance of HRV While Lying (LF/HF) Week 24, n=12	6.5774 Ratio Standard Deviation 9.07676
Variance of HRV While Lying (LF/HF) Week 28, n=10	6.6424 Ratio Standard Deviation 7.53794
Variance of HRV While Lying (LF/HF) Week 32, n=10	5.8556 Ratio Standard Deviation 7.19624
Variance of HRV While Lying (LF/HF) Week 36, n=9	15.4940 Ratio Standard Deviation 30.00587
Variance of HRV While Lying (LF/HF) Week 40, n=11	4.5088 Ratio Standard Deviation 3.56720
Variance of HRV While Lying (LF/HF) Week 44, n=11	6.4731 Ratio Standard Deviation 6.29614
Variance of HRV While Lying (LF/HF) Week 48, n=11	11.7375 Ratio Standard Deviation 13.64105

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Mean HRV While Sedentary Not Lying (LF/HF) Week 20, n=10	6.0958 Ratio Standard Deviation 3.05182
Mean HRV While Sedentary Not Lying (LF/HF) Week 24, n=10	6.3113 Ratio Standard Deviation 3.03599
Mean HRV While Sedentary Not Lying (LF/HF) Week 36, n=11	6.6827 Ratio Standard Deviation 2.73499
Mean HRV While Sedentary Not Lying (LF/HF) Week 40, n=9	4.8166 Ratio Standard Deviation 2.16486
Mean HRV While Sedentary Not Lying (LF/HF) Week 0, n=20	5.2011 Ratio Standard Deviation 2.48369
Mean HRV While Sedentary Not Lying (LF/HF) Week 4, n=18	5.3944 Ratio Standard Deviation 2.83547
Mean HRV While Sedentary Not Lying (LF/HF) Week 8, n=13	5.1733 Ratio Standard Deviation 2.29737
Mean HRV While Sedentary Not Lying (LF/HF) Week 12, n=14	6.3760 Ratio Standard Deviation 3.42063
Mean HRV While Sedentary Not Lying (LF/HF) Week 16, n=11	6.0905 Ratio Standard Deviation 3.68543
Mean HRV While Sedentary Not Lying (LF/HF) Week 28, n=9	5.4652 Ratio Standard Deviation 3.20703
Mean HRV While Sedentary Not Lying (LF/HF) Week 32, n=9	8.3196 Ratio Standard Deviation 5.37661
Mean HRV While Sedentary Not Lying (LF/HF) Week 44, n=9	5.6220 Ratio Standard Deviation 2.61752
Mean HRV While Sedentary Not Lying (LF/HF) Week 48, n=7	5.8935 Ratio Standard Deviation 3.22033

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Variance of HRV While Sedentary Not Lying (LF/HF) Week 0, n=20	6.3439 Ratio Standard Deviation 6.55782
Variance of HRV While Sedentary Not Lying (LF/HF) Week 4, n=18	6.8401 Ratio Standard Deviation 6.49766
Variance of HRV While Sedentary Not Lying (LF/HF) Week 8, n=13	5.3481 Ratio Standard Deviation 4.86394
Variance of HRV While Sedentary Not Lying (LF/HF) Week 12, n=14	11.4190 Ratio Standard Deviation 11.42238
Variance of HRV While Sedentary Not Lying (LF/HF) Week 16, n=11	16.1974 Ratio Standard Deviation 20.59606
Variance of HRV While Sedentary Not Lying (LF/HF) Week 20, n=10	10.2248 Ratio Standard Deviation 13.69276
Variance of HRV While Sedentary Not Lying (LF/HF) Week 24, n=10	6.5774 Ratio Standard Deviation 9.07676
Variance of HRV While Sedentary Not Lying (LF/HF) Week 28, n=9	6.6424 Ratio Standard Deviation 7.53794
Variance of HRV While Sedentary Not Lying (LF/HF) Week 32, n=9	5.8556 Ratio Standard Deviation 7.19624
Variance of HRV While Sedentary Not Lying (LF/HF) Week 36, n=11	15.4940 Ratio Standard Deviation 30.00587
Variance of HRV While Sedentary Not Lying (LF/HF) Week 40, n=9	4.5088 Ratio Standard Deviation 3.56720
Variance of HRV While Sedentary Not Lying (LF/HF) Week 44, n=9	6.4731 Ratio Standard Deviation 6.29614
Variance of HRV While Sedentary Not Lying (LF/HF) Week 48, n=7	11.7375 Ratio Standard Deviation 13.64105

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was \<=1

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Mean HRV While Active (LF/HF) Week 0, n=2	4.3350 Ratio Standard Deviation 0.09192
Mean HRV While Active (LF/HF) Week 4, n=1	3.8100 Ratio Standard Deviation NA Standard deviation could not be calculated when number of participants was \<=1

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Variance of HRV While Active (LF/HF) Week 0, n=2	0.0000 Ratio Standard Deviation 0.0000
Variance of HRV While Active (LF/HF) Week 4, n=1	0.0000 Ratio Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

The effect of being upright on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 8, n=13	1.1937 Ratio Standard Deviation 2.40299
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 12, n=14	2.1585 Ratio Standard Deviation 2.80355
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 16, n=11	2.5080 Ratio Standard Deviation 3.40632
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 20, n=10	2.4613 Ratio Standard Deviation 3.64555
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 24, n=10	2.5161 Ratio Standard Deviation 1.95702
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 28, n=9	-0.1964 Ratio Standard Deviation 6.11226
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 40, n=9	0.9722 Ratio Standard Deviation 1.73768
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 0, n=20	1.0563 Ratio Standard Deviation 2.12227
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 32, n=9	3.3476 Ratio Standard Deviation 5.59881
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 4, n=18	1.3507 Ratio Standard Deviation 2.56807
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 36, n=9	2.5583 Ratio Standard Deviation 3.74969
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 44, n=9	1.6069 Ratio Standard Deviation 2.71641
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) Week 48, n=6	1.5796 Ratio Standard Deviation 3.73597

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

The effect of being upright on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 8, n=13	-2.0885 Ratio Standard Deviation 9.89872
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 12, n=14	4.1473 Ratio Standard Deviation 8.03699
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 16, n=11	9.8909 Ratio Standard Deviation 21.83721
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 20, n=10	2.9204 Ratio Standard Deviation 17.31637
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 28, n=9	-13.6310 Ratio Standard Deviation 45.52591
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 32, n=9	-8.9054 Ratio Standard Deviation 19.69942
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 36, n=9	10.3525 Ratio Standard Deviation 35.50938
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 40, n=9	-3.8092 Ratio Standard Deviation 8.66934
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 44, n=9	-2.1221 Ratio Standard Deviation 11.81571
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 48, n=6	4.3165 Ratio Standard Deviation 16.66785
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 0, n=20	-0.0750 Ratio Standard Deviation 5.21420
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 4, n=18	-5.5005 Ratio Standard Deviation 28.71903
Effect of Being Upright on HRV Variance (LF/HF Analysis) Week 24, n=10	-1.1979 Ratio Standard Deviation 2.96892

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

The effect of activity on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Effect of Activity on Mean HRV (LF/HF) Week 0; n= 2	-1.6117 Ratio Standard Deviation 2.88735
Effect of Activity on Mean HRV (LF/HF) Week 4; n= 1	0.9367 Ratio Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

The effect of activity on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Effect of Activity on HRV Variance (LF/HF Analysis) Week 0; n= 2	-8.6500 Ratio Standard Deviation 5.93027
Effect of Activity on HRV Variance (LF/HF Analysis) Week 4; n= 1	-3.4367 Ratio Standard Deviation NA NA indicates that data could not be calculated as participant number was \<=1.

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 0, n=24	21.2445 Milliseconds^2 Standard Deviation 6.13882
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 4, n=21	20.0394 Milliseconds^2 Standard Deviation 6.61338
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 8, n=15	22.4551 Milliseconds^2 Standard Deviation 5.98867
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 12, n=16	20.6744 Milliseconds^2 Standard Deviation 6.95469
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 48, n=12	19.5152 Milliseconds^2 Standard Deviation 8.04882
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 16, n=12	20.7926 Milliseconds^2 Standard Deviation 7.01048
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 20, n=12	20.7321 Milliseconds^2 Standard Deviation 6.80432
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 24, n=12	21.3250 Milliseconds^2 Standard Deviation 6.92749
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 28, n=10	21.7888 Milliseconds^2 Standard Deviation 7.14731
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 32, n=10	21.1318 Milliseconds^2 Standard Deviation 8.08213
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 36, n=11	20.8849 Milliseconds^2 Standard Deviation 5.72665
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 40, n=11	20.0684 Milliseconds^2 Standard Deviation 7.98572
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Week 44, n=11	20.2980 Milliseconds^2 Standard Deviation 5.95832

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 0, n=24	35.3316 Milliseconds^2 Standard Deviation 25.70628
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 4, n=21	26.2719 Milliseconds^2 Standard Deviation 19.19169
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 8, n=15	34.5477 Milliseconds^2 Standard Deviation 18.01341
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 12, n=16	31.8929 Milliseconds^2 Standard Deviation 28.36635
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 28, n=10	45.4243 Milliseconds^2 Standard Deviation 62.35269
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 32, n=10	30.5288 Milliseconds^2 Standard Deviation 24.91715
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 36, n=11	24.8373 Milliseconds^2 Standard Deviation 14.41668
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 40, n=11	18.4227 Milliseconds^2 Standard Deviation 9.54924
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 44, n=11	22.5279 Milliseconds^2 Standard Deviation 10.78475
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 16, n=12	34.8321 Milliseconds^2 Standard Deviation 25.62477
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 20, n=12	41.4669 Milliseconds^2 Standard Deviation 36.88159
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 24, n=12	34.3781 Milliseconds^2 Standard Deviation 38.27469
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis Week 48, n=12	15.7176 Milliseconds^2 Standard Deviation 13.15760

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Mean HRV effect of being upright v/s ALSFRS-R;n=24	0.139 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Mean LF/HF (lying down) (1) v/s ALSFRS-R;n=25	0.228 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Mean LF/HF sedentary (not lying) v/s ALSFRS-R;n=24	0.023 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Var. LF/HF sedentary (not lying) v/s ALSFR-R;n=24	-0.041 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Mean HRV effect of activity v/s ALSFRS-R;n=3	0.421 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Mean LF/HF (avg-daytime activity) v/s ALSFRS-R;n=3	-0.921 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Var of HRV effect of activity v/s ALSFRS-R;n=3	0.419 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Var of HRV effect being upright v/s ALSFRS-R;n=24	0.308 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Var of LF/HF (lying down) v/s ALSFRS-R;n=25	-0.378 Ratio
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R Var of LF/HF v/s ALSFRS-R;n=3	NA Ratio NA indicates that sample size is insufficient to calculate the correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Full Analysis Set

Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Measurement of Speech Quality Jitter;Week48;n=18 (Short ah)	0.379 Hertz Standard Deviation 0.2949
Measurement of Speech Quality Jitter;EWD;n=2 (Short ah)	0.435 Hertz Standard Deviation 0.1835
Measurement of Speech Quality Shimmer;Week0;n=25 (Short ah)	5.099 Hertz Standard Deviation 1.0892
Measurement of Speech Quality Shimmer;Week12;n=18 (Short ah)	5.031 Hertz Standard Deviation 1.0850
Measurement of Speech Quality Shimmer;Week24;n=17 (Short ah)	5.498 Hertz Standard Deviation 1.1896
Measurement of Speech Quality Shimmer;Week36;n=15 (Short ah)	5.203 Hertz Standard Deviation 1.4083
Measurement of Speech Quality Shimmer;Week48;n=18 (Short ah)	5.157 Hertz Standard Deviation 1.9564
Measurement of Speech Quality Shimmer;EWD;n=2 (Short ah)	5.624 Hertz Standard Deviation 1.5979
Measurement of Speech Quality CTF F0;Week0;n=25 (Long ah)	134.443 Hertz Standard Deviation 33.2237
Measurement of Speech Quality CTF F0;Week12;n=18 (Long ah)	122.620 Hertz Standard Deviation 35.6641
Measurement of Speech Quality CTF F0;Week48;n=18 (Long ah)	134.198 Hertz Standard Deviation 48.3046
Measurement of Speech Quality CTF F0;EWD;n=3 (Long ah)	179.844 Hertz Standard Deviation 25.7371
Measurement of Speech Quality Jitter;Week0;n=25 (Long ah)	0.148 Hertz Standard Deviation 0.1701
Measurement of Speech Quality Jitter;Week12;n=18 (Long ah)	0.098 Hertz Standard Deviation 0.0697
Measurement of Speech Quality Jitter;Week24;n=17 (Long ah)	0.178 Hertz Standard Deviation 0.3030
Measurement of Speech Quality Jitter;Week36;n=15 (Long ah)	0.229 Hertz Standard Deviation 0.3069
Measurement of Speech Quality Shimmer;Week48;n=18 (Long ah)	3.046 Hertz Standard Deviation 1.4476
Measurement of Speech Quality Shimmer;EWD;n=2 (Long ah)	2.767 Hertz Standard Deviation 0.0709
Measurement of Speech Quality CTF F0;Week0;n=25 (Short ah)	151.829 Hertz Standard Deviation 44.5983
Measurement of Speech Quality CTF F0;Week12;n=18 (Short ah)	156.506 Hertz Standard Deviation 42.0801
Measurement of Speech Quality CTF F0;Week24;n=17 (Short ah)	143.481 Hertz Standard Deviation 43.8646
Measurement of Speech Quality CTF F0;Week36;n=15 (Short ah)	151.192 Hertz Standard Deviation 43.1685
Measurement of Speech Quality CTF F0;Week48;n=18 (Short ah)	156.418 Hertz Standard Deviation 71.9125
Measurement of Speech Quality CTF F0;EWD;n=3 (Short ah)	176.229 Hertz Standard Deviation 76.2851
Measurement of Speech Quality Jitter;Week0;n=25 (Short ah)	0.405 Hertz Standard Deviation 0.2814
Measurement of Speech Quality Jitter;Week12;n=18 (Short ah)	0.531 Hertz Standard Deviation 0.2956
Measurement of Speech Quality Jitter;Week24;n=17 (Short ah)	0.415 Hertz Standard Deviation 0.3345
Measurement of Speech Quality Jitter;Week36;n=15 (Short ah)	0.429 Hertz Standard Deviation 0.2987
Measurement of Speech Quality CTF F0;Week24;n=17 (Long ah)	146.295 Hertz Standard Deviation 63.0013
Measurement of Speech Quality CTF F0;Week36;n=15 (Long ah)	145.575 Hertz Standard Deviation 45.5629
Measurement of Speech Quality Jitter;Week48;n=18 (Long ah)	0.148 Hertz Standard Deviation 0.1309
Measurement of Speech Quality Jitter;EWD;n=2 (Long ah)	0.304 Hertz Standard Deviation 0.3115
Measurement of Speech Quality Shimmer;Week0;n=25 (Long ah)	2.926 Hertz Standard Deviation 1.0166
Measurement of Speech Quality Shimmer;Week12;n=18 (Long ah)	3.192 Hertz Standard Deviation 0.8599
Measurement of Speech Quality Shimmer;Week24;n=17 (Long ah)	3.082 Hertz Standard Deviation 1.1959
Measurement of Speech Quality Shimmer;Week36;n=15 (Long ah)	2.872 Hertz Standard Deviation 1.2162

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: Safety Population

Outcome measures

Outcome measures
Measure	Mega Faros Device + Fast Fix n=25 Participants In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures SAEs	0 Events
Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures AEs	6 Events

Adverse Events

Mega Faros Device + Fast Fix

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mega Faros Device + Fast Fix n=25 participants at risk During Pilot phase,subjects will attend clinic at least once to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). During 48 week Core Study, subjects will attend 5 clinic visits to perform gold standard measures of function (ALS Functional Rating Scale-Revised and Forced Vital Capacity) and perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visits (home monitoring). In between clinic visits, subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period
Skin and subcutaneous tissue disorders Dermatitis contact	16.0% 4/25 • On-treatment SAEs and non-serious AEs were collected from start of study treatment until Week 48. On-treatment SAEs and non-serious AEs are reported for Safety Population
Skin and subcutaneous tissue disorders Rash	8.0% 2/25 • On-treatment SAEs and non-serious AEs were collected from start of study treatment until Week 48. On-treatment SAEs and non-serious AEs are reported for Safety Population
Skin and subcutaneous tissue disorders Rash pruritic	4.0% 1/25 • On-treatment SAEs and non-serious AEs were collected from start of study treatment until Week 48. On-treatment SAEs and non-serious AEs are reported for Safety Population
Skin and subcutaneous tissue disorders Skin irritation	4.0% 1/25 • On-treatment SAEs and non-serious AEs were collected from start of study treatment until Week 48. On-treatment SAEs and non-serious AEs are reported for Safety Population

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER