Trial Outcomes & Findings for Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness (NCT NCT02791893)
NCT ID: NCT02791893
Last Updated: 2021-05-03
Results Overview
Patients used the Pain Visual Analog Scale (0-10; 0=No pain, 10=Worst pain possible) to rate their average level of pain over the last 24 hours. The median value for each individual's ratings over 5 consecutive days immediately prior to the end of the intervention period was recorded and then the average was calculated for each group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
10 and 20 weeks
Results posted on
2021-05-03
Participant Flow
We started with 29 veterans, recruited at the East Orange VA, who agreed to participate. Of these, 27 actually came to the Icahn School of Medicine at Mount Sinai where they signed an informed consent and were randomized. From that sample, 20 veterans completed the blinded phase of the study and 15 completed the entire study including open trial.
Participant milestones
| Measure |
VNS Device
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Blinded Phase
STARTED
|
13
|
14
|
|
Blinded Phase
COMPLETED
|
10
|
10
|
|
Blinded Phase
NOT COMPLETED
|
3
|
4
|
|
Open Label Phase
STARTED
|
10
|
10
|
|
Open Label Phase
COMPLETED
|
7
|
8
|
|
Open Label Phase
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
VNS Device
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Blinded Phase
Lost to Follow-up
|
2
|
2
|
|
Blinded Phase
Withdrawal by Subject
|
1
|
2
|
|
Open Label Phase
Lost to Follow-up
|
3
|
0
|
|
Open Label Phase
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
Baseline characteristics by cohort
| Measure |
VNS Device
n=13 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=14 Participants
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.92 years
STANDARD_DEVIATION 7.11 • n=5 Participants
|
55.46 years
STANDARD_DEVIATION 5.72 • n=7 Participants
|
54.19 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Pain Visual Analog Scale (0-10)
|
6.23 units on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
6.82 units on a scale
STANDARD_DEVIATION 1.23 • n=7 Participants
|
6.54 units on a scale
STANDARD_DEVIATION 1.05 • n=5 Participants
|
|
Physical Function Subscale from the Short Form Health Survey (SF-36)
|
46.15 Normalized units on a scale
STANDARD_DEVIATION 22.28 • n=5 Participants
|
40.00 Normalized units on a scale
STANDARD_DEVIATION 22.01 • n=7 Participants
|
42.96 Normalized units on a scale
STANDARD_DEVIATION 21.94 • n=5 Participants
|
|
Number of Headache Days collected from the Migraine Disability assessment (MIDAS)
|
8.38 Days
STANDARD_DEVIATION 9.59 • n=5 Participants
|
14.21 Days
STANDARD_DEVIATION 24.28 • n=7 Participants
|
11.41 Days
STANDARD_DEVIATION 18.60 • n=5 Participants
|
|
Depression subscale from the Hospital Anxiety and Depression Scale (HADS)
|
9.46 Units on a scale
STANDARD_DEVIATION 2.26 • n=5 Participants
|
11.00 Units on a scale
STANDARD_DEVIATION 1.88 • n=7 Participants
|
10.26 Units on a scale
STANDARD_DEVIATION 2.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 and 20 weeksPopulation: The 10-week measure includes only those individuals who completed the blinded phase of the study. The 20-week measure includes only those individuals who completed the open label phase of the study.
Patients used the Pain Visual Analog Scale (0-10; 0=No pain, 10=Worst pain possible) to rate their average level of pain over the last 24 hours. The median value for each individual's ratings over 5 consecutive days immediately prior to the end of the intervention period was recorded and then the average was calculated for each group.
Outcome measures
| Measure |
VNS Device
n=10 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=10 Participants
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Visual Analog Scale (VAS) to Assess Change of Widespread Pain
10 weeks
|
4.70 Units on a scale
Standard Deviation 2.41
|
5.40 Units on a scale
Standard Deviation 2.27
|
|
Visual Analog Scale (VAS) to Assess Change of Widespread Pain
20 weeks
|
5.43 Units on a scale
Standard Deviation 2.07
|
3.56 Units on a scale
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: Baseline and 20 weeksPopulation: Regardless of the original condition assignment, outcomes from baseline and after the open-label period are compared. All patients received at least 10 weeks of active VNS therapy.
Patients used the Pain Visual Analog Scale (0-10; 0=No pain, 10=Worst pain possible) to rate their average level of pain over the last 24 hours. The median value for each individual's ratings over 5 consecutive days immediately prior to the end of the intervention period was recorded and then the average was calculated for each group.
Outcome measures
| Measure |
VNS Device
n=20 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Visual Analog Scale (VAS) to Assess Change of Widespread Pain
Baseline
|
6.18 Units on a scale
Standard Deviation 0.82
|
—
|
|
Visual Analog Scale (VAS) to Assess Change of Widespread Pain
20 weeks
|
4.43 Units on a scale
Standard Deviation 1.94
|
—
|
SECONDARY outcome
Timeframe: 10 and 20 weeksPopulation: The 10-week measure includes only those individuals who completed the blinded phase of the study. The 20-weel measure includes only those individuals who completed the open label phase of the study.
PGIC is a 7-point scale used to quantify a patient's rating of overall improvement. Patients rate their change from 1 (no change or gotten worse) to 7 (considerable improvement). Higher scores indicate greater improvement since starting the intervention.
Outcome measures
| Measure |
VNS Device
n=10 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=10 Participants
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Patient Global Improvement of Change (PGIC)
10 weeks
|
4.00 Score on a scale
Standard Deviation 2.06
|
3.11 Score on a scale
Standard Deviation 1.90
|
|
Patient Global Improvement of Change (PGIC)
20 weeks
|
3.71 Score on a scale
Standard Deviation 1.98
|
5.37 Score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 10 and 20 weeksPopulation: The 10-week measure includes only those individuals who completed the blinded phase of the study. The 20-weel measure includes only those individuals who completed the open label phase of the study.
A normalized indicator of physical functioning with a range from 0-100. Higher scores indicate fewer limitations to activity.
Outcome measures
| Measure |
VNS Device
n=10 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=10 Participants
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Physical Function Subscale From the Short Form Health Survey (SF-36)
10 weeks
|
65.50 Score on a scale
Standard Deviation 19.78
|
55.56 Score on a scale
Standard Deviation 24.81
|
|
Physical Function Subscale From the Short Form Health Survey (SF-36)
20 weeks
|
60.71 Score on a scale
Standard Deviation 32.97
|
56.25 Score on a scale
Standard Deviation 27.35
|
SECONDARY outcome
Timeframe: 10 and 20 weeksPopulation: The 10-week measure includes only those individuals who completed the blinded phase of the study. The 20-weel measure includes only those individuals who completed the open label phase of the study.
Participants are asked to indicate the number of days in the last 3 months during which they experienced a headache. If a headache lasted more than 1 day, they are instructed to count each day. Scores are expected between 0-90 with higher numbers corresponding to a greater number of headache days.
Outcome measures
| Measure |
VNS Device
n=10 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=10 Participants
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Number of Headache Days Collected From the Migraine Disability Assessment (MIDAS).
10 weeks
|
4.10 Days
Standard Deviation 6.76
|
13.78 Days
Standard Deviation 23.49
|
|
Number of Headache Days Collected From the Migraine Disability Assessment (MIDAS).
20 weeks
|
6.29 Days
Standard Deviation 10.63
|
14.25 Days
Standard Deviation 25.58
|
SECONDARY outcome
Timeframe: 10 and 20 weeksPopulation: The 10-week measure includes only those individuals who completed the blinded phase of the study. The 20-weel measure includes only those individuals who completed the open label phase of the study.
The HADS is a 14-item scale intended to quantify symptoms of depression and anxiety. Scores range from 0-21 on each subscale (Anxiety and Depression) with higher scores indicating a greater number of symptoms.
Outcome measures
| Measure |
VNS Device
n=10 Participants
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=10 Participants
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Depression Subscale From the Hospital Anxiety and Depression Scale (HADS)
10 weeks
|
9.00 Units on a scale
Standard Deviation 2.26
|
10.11 Units on a scale
Standard Deviation 1.05
|
|
Depression Subscale From the Hospital Anxiety and Depression Scale (HADS)
20 weeks
|
7.50 Units on a scale
Standard Deviation 1.05
|
9.75 Units on a scale
Standard Deviation 2.25
|
Adverse Events
VNS Device
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Inactive Device
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VNS Device
n=13 participants at risk
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=14 participants at risk
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
General disorders
Chest pains occurred shortly after randomization
|
7.7%
1/13 • Number of events 1 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
0.00%
0/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
Other adverse events
| Measure |
VNS Device
n=13 participants at risk
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
|
Inactive Device
n=14 participants at risk
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
VNS device: Hand held device to use for self administration of vagus nerve stimulation.
Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
0.00%
0/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Burning/stinging sensation
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
7.1%
1/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Dizziness
|
0.00%
0/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
7.1%
1/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
Musculoskeletal and connective tissue disorders
Facial droops
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
7.1%
1/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
Gastrointestinal disorders
Frequent stools
|
0.00%
0/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
7.1%
1/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Headache
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
21.4%
3/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Lightheadedness
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
0.00%
0/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
Musculoskeletal and connective tissue disorders
Lip droop/quiver
|
15.4%
2/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
14.3%
2/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Metallic taste
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
21.4%
3/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
2/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
21.4%
3/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Muscle tightness
|
23.1%
3/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
14.3%
2/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Numbness
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
0.00%
0/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Pain/radiating pain
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
14.3%
2/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
Skin and subcutaneous tissue disorders
Redness/irritation
|
15.4%
2/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
21.4%
3/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
Skin and subcutaneous tissue disorders
Small bumps
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
0.00%
0/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Swelling
|
7.7%
1/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
0.00%
0/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Tenderness
|
15.4%
2/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
7.1%
1/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
|
General disorders
Tingling sensation
|
23.1%
3/13 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
21.4%
3/14 • Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
|
Additional Information
Dr. Benjamin Natelson
Mount Sinai Beth Israel, New York, NY
Phone: 212-844-6768
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place