Back to resultsExploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Faros Sensor (FS) and LifeInsight Hub
Fast Fix electrode patch
Quantitative Measure of Speech (Core Phase Only)
Sponsored by
About this trial
This is an interventional other trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Biotelemetry
Eligibility Criteria
Inclusion Criteria:
- Between 18 and 80 years of age, inclusive, at the time of signing the informed consent.
- Diagnosed with ALS by a neurologist with expertise in ALS. For subjects with bulbar onset there must be objective limb involvement of at least one limb.
- Diagnosed with ALS within 18 months of symptom onset.
- Subjects must be ambulatory (i.e., must not be confined to a wheelchair).
- Male and female subjects.
- Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol which includes compliance with the requirements and restrictions listed in the consent form and in protocol.
- Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
Exclusion Criteria:
- Neurological (other than the subject's ALS) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility.
- Clinically significant cognitive impairment in the opinion of the investigator.
- Regionally restricted forms of ALS, or other atypical variants: Isolated corticobulbar pattern of ALS with normal ambulation; Flail arm syndrome; Primary lateral sclerosis; Signs of chronic partial denervation restricted to a single limb; ALS parkinsonism dementia complex
- Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed).
- Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints.
- Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
- History of skin hypersensitivity to adhesives.
- Current participation in a clinical trial which in the opinion of the investigator and GSK medical monitor might impact the objectives of this study.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot and Core Study Phase
Arm Description
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
Outcomes
Primary Outcome Measures
Duration of Day Time Wear Time of the Device
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02447952
Brief Title
Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis
Official Title
An Exploratory Study to Investigate the Use of Biotelemetry to Identify Markers of Disease Progression in Subjects With Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 30, 2015 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit 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 (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 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, every month 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.
All third party trademark rights are the rights of their respective owners.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Biotelemetry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot and Core Study Phase
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Faros Sensor (FS) and LifeInsight Hub
Intervention Description
Each subject will be issued one FS and a MAT LifeInsight Hub for use during the study. At each clinic visit in the Pilot and Core Study Phases, the Faros sensor will be placed on the subject just prior to the defined reference tasks and will be worn on the subject's sternum during completion of the tasks. The morning after the clinic visit, the subject will re-attach the sensor and wear it for approximately 3 days. In between visits during the Core Study Phase the subject will wear the FS every month for approximately 3 days to enable data collection on a monthly basis over the 48 week study period. Movement/physical activity data will be collected by the FS throughout the study.
Intervention Type
Device
Intervention Name(s)
Fast Fix electrode patch
Intervention Description
The Fast Fix electrode patch will be worn with the FS on the subject's sternum according to the same schedule as the FS. The Fast Fix electrode patch will be replaced by the subject on a daily basis during the 3 day monitoring period. Subjects will be provided instructions on how to operate and wear the Fast Fix electrode patch.
Intervention Type
Procedure
Intervention Name(s)
Quantitative Measure of Speech (Core Phase Only)
Intervention Description
Subjects will follow simple prompts on a computer screen instructing them to say a series of vowels, words, and paragraphs which will be recorded using a high definition digital microphone and stored securely on a laptop. The speech waveform data will be sent via secure method to GSK/MAT for processing.
Primary Outcome Measure Information:
Title
Duration of Day Time Wear Time of the Device
Description
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.
Time Frame
Up to Week 48
Other Pre-specified Outcome Measures:
Title
Duration of Night Time Wear Time of the Device
Description
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.
Time Frame
Up to Week 48
Title
Average Time Spent Active
Description
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)
Time Frame
Up to Week 48
Title
Average Time Spent 'Sedentary Not Lying'
Description
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).
Time Frame
Up to Week 48
Title
Average Time Spent Lying
Description
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).
Time Frame
Up to Week 48
Title
Average Time Spent Sedentary.
Description
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).
Time Frame
Up to Week 48
Title
Time Spent With Sensor Off
Description
Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.
Time Frame
Up to Week 48
Title
Total Activity Count
Description
Total activity count for the day time and night time for 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).
Time Frame
Up to Week 48
Title
Maximum Activity Count in a 24 Hour Period
Description
Maximum activity count for the day time and night time for 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)
Time Frame
Up to Week 48
Title
Mean Maximum Activity Count in a 24 Hour Period
Description
Mean maximum activity count of day time and night time for 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)
Time Frame
Up to Week 48
Title
Number of Continuous Active Periods
Description
Active periods were catagorized as >1minute to <=2minutes, >2 minutes to <=5minutes, >5 minutes to <=15 minutes, >15 minutes to <=30 minutes, >30 minutes. Total number of 'active periods were calculated as 1minute<x<2minutes + 'number of active periods 2minutes<x<5minutes + 'number of active periods 5minutes<x<15minutes + 'number of active periods 15minutes<x<30minutes + 'number of active periods >30minutes.
Time Frame
Up to Week 48
Title
Percent of Time Lying Down at Night
Description
Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint
Time Frame
Up to Week 48
Title
Number of Night Time Movement Episodes Per Hour
Description
Average number of night movement episodes per hour 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).
Time Frame
Up to Week 48
Title
Percent Time Night-time Rest Efficiency
Description
Average night-time rest efficiency 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)
Time Frame
Up to Week 48
Title
Rest Fragmentation Index
Description
Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes 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).
Time Frame
Up to Week 48
Title
Average Duration of Night Time Movement Episodes
Description
Average duration of movement episodes 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).
Time Frame
Up to Week 48
Title
Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R
Description
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. Data for between subject correlation coefficient has been presented
Time Frame
Up to Week 48
Title
Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R
Description
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. Data for between subject correlation coefficient has been presented
Time Frame
Up to Week 48
Title
Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R
Description
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. Data for between subject correlation coefficient has been presented
Time Frame
Up to Week 48
Title
Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R
Description
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. Data for between subject correlation coefficient has been presented
Time Frame
Up to Week 48
Title
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])
Description
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).
Time Frame
Up to Week 48
Title
Variance of HRV While Lying (LF/HF)
Description
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).
Time Frame
Up to Week 48
Title
Mean HRV While Sedentary Not Lying (LF/HF)
Description
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).
Time Frame
Up to Week 48
Title
Variance of HRV While Sedentary Not Lying (LF/HF)
Description
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).
Time Frame
Up to Week 48
Title
Mean HRV While Active (LF/HF)
Description
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
Time Frame
Up to Week 48
Title
Variance of HRV While Active (LF/HF)
Description
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
Time Frame
Up to Week 48
Title
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)
Description
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).
Time Frame
Up to Week 48
Title
Effect of Being Upright on HRV Variance (LF/HF Analysis)
Description
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).
Time Frame
Up to Week 48
Title
Effect of Activity on Mean HRV (LF/HF)
Description
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.
Time Frame
Up to Week 48
Title
Effect of Activity on HRV Variance (LF/HF Analysis)
Description
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.
Time Frame
Up to Week 48
Title
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)
Description
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).
Time Frame
Up to Week 48
Title
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis
Description
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).
Time Frame
Up to Week 48
Title
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R
Description
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
Time Frame
Up to Week 48
Title
Measurement of Speech Quality
Description
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).
Time Frame
Up to Week 48
Title
Duration of Maximum Gap Between Words
Description
Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.
Time Frame
Up to Week 48
Title
Speaking Rate
Description
Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Average Phoneme Rate
Description
Phoneme rate was analyzed for the single word "doily". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Maximum Phonation Time
Description
Maximum phonation time for the single word "doily" test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Seconds
Title
Percentage Pause Time
Description
Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R
Description
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below
Time Frame
Up to Week 48
Title
Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC
Description
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below
Time Frame
Up to Week 48
Title
Number of Participants Reporting Sensor Comfort
Description
Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Number of Participants Reporting Impact on Sleep
Description
Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Number of Participants With Ease of Setting up and Attaching the Sensor
Description
The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Number of Participants With Corresponding Activity Level Required to Complete Their Job
Description
The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor
Description
Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Number of Participants Whose Sensor Fell Off
Description
The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame
Up to Week 48
Title
Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures
Description
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.
Time Frame
Up to Week 48
Title
Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures
Description
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented
Time Frame
Up to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 18 and 80 years of age, inclusive, at the time of signing the informed consent.
Diagnosed with ALS by a neurologist with expertise in ALS. For subjects with bulbar onset there must be objective limb involvement of at least one limb.
Diagnosed with ALS within 18 months of symptom onset.
Subjects must be ambulatory (i.e., must not be confined to a wheelchair).
Male and female subjects.
Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol which includes compliance with the requirements and restrictions listed in the consent form and in protocol.
Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
Exclusion Criteria:
Neurological (other than the subject's ALS) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility.
Clinically significant cognitive impairment in the opinion of the investigator.
Regionally restricted forms of ALS, or other atypical variants: Isolated corticobulbar pattern of ALS with normal ambulation; Flail arm syndrome; Primary lateral sclerosis; Signs of chronic partial denervation restricted to a single limb; ALS parkinsonism dementia complex
Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed).
Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints.
Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
History of skin hypersensitivity to adhesives.
Current participation in a clinical trial which in the opinion of the investigator and GSK medical monitor might impact the objectives of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis
We'll reach out to this number within 24 hrs