Trial Outcomes & Findings for Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS) (NCT NCT06268288)
NCT ID: NCT06268288
Last Updated: 2025-10-31
Results Overview
The change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline; 8 Weeks
Results posted on
2025-10-31
Participant Flow
Participant milestones
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome Management/ STEPS
n=20 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (Noninvasive Vagal Nerve Stimulation)
n=20 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 3 • n=20 Participants
|
16 years
STANDARD_DEVIATION 3 • n=20 Participants
|
15 years
STANDARD_DEVIATION 3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline; 8 WeeksThe change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=13 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=15 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
The Change in Composite Autonomic Symptom Score (COMPASS-31)
|
-5.40 score on a scale
Standard Deviation 6.82
|
-5.94 score on a scale
Standard Deviation 10.89
|
PRIMARY outcome
Timeframe: Baseline; 8 WeeksThe change in Child Functional Disability Inventory scores from baseline to eight weeks. The Child Functional Disability Inventory assesses the physical and psychosocial functioning of children due to their physical health. It consists of 15 items that measure activity limitations due to being sick or not feeling well. The total scores range from 0 to 60 with higher scores indicating greater perceived functional disability.
Outcome measures
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=13 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=15 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
The Change in Child Functional Disability Inventory Scores
|
-2.92 score on a scale
Standard Deviation 8.60
|
-3.40 score on a scale
Standard Deviation 11.76
|
PRIMARY outcome
Timeframe: Baseline; 8 WeeksPopulation: Everyone had a baseline head up tilt table test. The repeat tilt table test was voluntary and resulted in fewer patients participating in this repeat test. The reason we made this voluntary is that many participants live far away and return for a repeat head up tilt table is inconvenient and costly.
The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.
Outcome measures
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=4 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=7 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests
Baseline
|
47.50 Beats per Minute (BPM)
Standard Deviation 6.45
|
58.14 Beats per Minute (BPM)
Standard Deviation 28.94
|
|
The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests
8 Weeks
|
42.50 Beats per Minute (BPM)
Standard Deviation 7.00
|
40.14 Beats per Minute (BPM)
Standard Deviation 14.35
|
SECONDARY outcome
Timeframe: Baseline; 8 WeeksPopulation: One patient in the standard POTS management/STEPS arm and two patients in the STEPS + GammaCore arm did not fill out the patient log at week 8 that documented the number of headaches they experienced. Due to this, no data exists for week 8 for these patients.
The change in the number of headaches from baseline to 8 weeks experienced by adolescent patients with POTS.
Outcome measures
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=15 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=15 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
Change in the Number of Headaches Experienced by Adolescent Patients With POTS
Baseline
|
1.00 Headaches
Interval 1.0 to 2.1
|
1.30 Headaches
Interval 0.7 to 3.1
|
|
Change in the Number of Headaches Experienced by Adolescent Patients With POTS
8 Weeks
|
1.20 Headaches
Interval 0.6 to 2.0
|
0.40 Headaches
Interval 0.0 to 1.7
|
SECONDARY outcome
Timeframe: Baseline; 8 WeeksPopulation: One patient in the standard POTS management/STEPS arm and two patients in the STEPS + GammaCore arm did not fill out the patient log at week 8 that documented exercise duration in minutes. Due to this, no data exists for week 8 for these patients.
The change in the exercise duration (minutes) in adolescent patients with POTS from baseline to 8 weeks.
Outcome measures
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=15 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=15 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
Change in Exercise Duration (Minutes) in Adolescent Patients With POTS
Baseline
|
25.00 Minutes
Interval 15.7 to 47.1
|
21.40 Minutes
Interval 8.6 to 45.7
|
|
Change in Exercise Duration (Minutes) in Adolescent Patients With POTS
8 Weeks
|
32.50 Minutes
Interval 18.6 to 55.7
|
17.90 Minutes
Interval 10.0 to 45.0
|
SECONDARY outcome
Timeframe: Baseline; 8 WeeksPopulation: Seven patients in the Device group and seven patients in the Control group had incomplete data for the PHQ-9 scores (missing either the baseline PHQ-9 survey or the final PHQ-8 at 8 weeks).
The change in the Patient Health Questionnaire 9-item (PHQ-9) scale score from baseline to 8 weeks. PHQ-9 is used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Outcome measures
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=13 Participants
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=13 Participants
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
Change in PHQ-9 Scores in Adolescent Patients With POTS
|
0.23 score on a scale
Standard Deviation 3.56
|
-3.39 score on a scale
Standard Deviation 4.54
|
Adverse Events
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
n=20 participants at risk
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
n=20 participants at risk
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
GammaCore intervention: Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
STEPS management protocol: STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals
|
|---|---|---|
|
Psychiatric disorders
Worsening Depression
|
0.00%
0/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
5.0%
1/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
|
Nervous system disorders
Increase Headaches
|
20.0%
4/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
20.0%
4/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
|
Nervous system disorders
Increased Dizziness
|
0.00%
0/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
15.0%
3/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
|
Gastrointestinal disorders
Bloating/Abdominal Pain
|
5.0%
1/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
15.0%
3/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
|
Psychiatric disorders
Increased Anxiety
|
0.00%
0/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
10.0%
2/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
|
Gastrointestinal disorders
Loose Stool
|
5.0%
1/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
0.00%
0/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
10.0%
2/20 • Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place