Trial Outcomes & Findings for The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (NCT NCT03674541)
NCT ID: NCT03674541
Last Updated: 2022-11-08
Results Overview
Define the response of oxygen uptake to pyridostigmine expressed both as mL/min and mL/min/kg. The difference in peak oxygen uptake from first iCPET to second iCPET. Research has shown that ME/CFS patients have inability to reproduce results on two consecutive cardiopulmonary exercise tests(CPET). Traditionally this is demonstrated with a two-day CPET protocol, but in this study we investigate the acute effects of pyridostigmine administration on the early stages of post exertional malaise(PEM).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Results posted on
2022-11-08
Participant Flow
Recruited from PI's clinic
Participant milestones
| Measure |
Study Drug - Pyridostigmine
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all participants underwent morphological and/or functional testing for small fiber neuropathy (SFN)
Baseline characteristics by cohort
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 Years
STANDARD_DEVIATION 16 • n=23 Participants
|
40 Years
STANDARD_DEVIATION 11 • n=16 Participants
|
50 Years
STANDARD_DEVIATION 20 • n=6 Participants
|
42 Years
STANDARD_DEVIATION 15 • n=45 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=23 Participants
|
16 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
39 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=23 Participants
|
12 Participants
n=16 Participants
|
4 Participants
n=6 Participants
|
37 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=23 Participants
|
4 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=45 Participants
|
|
Body Mass Index (BMI)
|
23.8 kg/m^2
STANDARD_DEVIATION 2.7 • n=23 Participants
|
23.0 kg/m^2
STANDARD_DEVIATION 4.1 • n=16 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 2.7 • n=6 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 3.3 • n=45 Participants
|
|
Hemoglobin
|
13.9 g/dL
STANDARD_DEVIATION 1.3 • n=23 Participants
|
14.0 g/dL
STANDARD_DEVIATION 1.1 • n=16 Participants
|
15.7 g/dL
STANDARD_DEVIATION 1.4 • n=6 Participants
|
14.2 g/dL
STANDARD_DEVIATION 1.3 • n=45 Participants
|
|
Hypertension
|
3 Participants
n=23 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=45 Participants
|
|
Dyslipidemia
|
1 Participants
n=23 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=45 Participants
|
|
Obesity
|
0 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=45 Participants
|
|
Cardiovascular Family History
|
13 Participants
n=23 Participants
|
11 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
26 Participants
n=45 Participants
|
|
Diabetes Mellitus
|
0 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=45 Participants
|
|
Previous Myocardial Infarction
|
0 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=45 Participants
|
|
Coronary Artery Disease
|
0 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=45 Participants
|
|
Statins
|
2 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=45 Participants
|
|
Beta Blockers
|
2 Participants
n=23 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=45 Participants
|
|
Acetylsalicylic Acid
|
2 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=45 Participants
|
|
Calcium Channel Blockers
|
1 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=45 Participants
|
|
Diuretics
|
1 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=45 Participants
|
|
Angiotensin-converting enzyme (ACE) Inhibitors
|
0 Participants
n=23 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=45 Participants
|
|
Objective Evidence of small fiber neuropathy by Morphological and/or Functional Testing
|
11 Participants
n=22 Participants • Not all participants underwent morphological and/or functional testing for small fiber neuropathy (SFN)
|
3 Participants
n=15 Participants • Not all participants underwent morphological and/or functional testing for small fiber neuropathy (SFN)
|
0 Participants
n=3 Participants • Not all participants underwent morphological and/or functional testing for small fiber neuropathy (SFN)
|
14 Participants
n=40 Participants • Not all participants underwent morphological and/or functional testing for small fiber neuropathy (SFN)
|
|
Epidermal Skin Biopsy Evidence of SFN
|
5 Participants
n=21 Participants • Not all participants underwent epidermal skin biopsies for small fiber neuropathy (SFN)
|
2 Participants
n=15 Participants • Not all participants underwent epidermal skin biopsies for small fiber neuropathy (SFN)
|
0 Participants
n=3 Participants • Not all participants underwent epidermal skin biopsies for small fiber neuropathy (SFN)
|
7 Participants
n=39 Participants • Not all participants underwent epidermal skin biopsies for small fiber neuropathy (SFN)
|
|
Sweat Gland Biopsy Evidence of SFN
|
5 Participants
n=8 Participants • Not all participants underwent sweat gland biopsies for small fiber neuropathy (SFN)
|
0 Participants
n=4 Participants • Not all participants underwent sweat gland biopsies for small fiber neuropathy (SFN)
|
0 Participants
n=3 Participants • Not all participants underwent sweat gland biopsies for small fiber neuropathy (SFN)
|
5 Participants
n=15 Participants • Not all participants underwent sweat gland biopsies for small fiber neuropathy (SFN)
|
|
Functional Testing (QSART and/or ESC) Evidence of SFN
|
1 Participants
n=10 Participants • Not all participants underwent functional testing (QSART and/or ESC) for small fiber neuropathy (SFN)
|
1 Participants
n=6 Participants • Not all participants underwent functional testing (QSART and/or ESC) for small fiber neuropathy (SFN)
|
0 Participants
n=3 Participants • Not all participants underwent functional testing (QSART and/or ESC) for small fiber neuropathy (SFN)
|
2 Participants
n=19 Participants • Not all participants underwent functional testing (QSART and/or ESC) for small fiber neuropathy (SFN)
|
|
POTS (Postural Orthostatic Tachycardia Syndrome)
|
13 Participants
n=23 Participants
|
5 Participants
n=16 Participants
|
1 Participants
n=6 Participants
|
19 Participants
n=45 Participants
|
|
Fibromyalgia
|
6 Participants
n=23 Participants
|
5 Participants
n=16 Participants
|
3 Participants
n=6 Participants
|
14 Participants
n=45 Participants
|
|
Mast Cell Activation Syndrome
|
4 Participants
n=23 Participants
|
3 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=45 Participants
|
|
Preceding Infection
|
12 Participants
n=23 Participants
|
8 Participants
n=16 Participants
|
4 Participants
n=6 Participants
|
24 Participants
n=45 Participants
|
|
Positive Antinuclear Antibody
|
7 Participants
n=23 Participants
|
3 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Define the response of oxygen uptake to pyridostigmine expressed both as mL/min and mL/min/kg. The difference in peak oxygen uptake from first iCPET to second iCPET. Research has shown that ME/CFS patients have inability to reproduce results on two consecutive cardiopulmonary exercise tests(CPET). Traditionally this is demonstrated with a two-day CPET protocol, but in this study we investigate the acute effects of pyridostigmine administration on the early stages of post exertional malaise(PEM).
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Change in Peak Oxygen Uptake (Peak VO2) Between the First and Second iCPET
|
13.3 mL/min
Standard Error 13.4
|
-40.3 mL/min
Standard Error 21.3
|
111.8 mL/min
Standard Error 65.0
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Peak versus rest changes in oxygen uptake between first and second CPETs expressed as mL/min.
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak-Rest Oxygen Uptake (VO2)
|
25.9 mL/min
Standard Error 15.3
|
-60.8 mL/min
Standard Error 25.6
|
121.8 mL/min
Standard Error 80.0
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Arterial and mixed-venous blood gases and pH are measured at peak exercise and Qc is calculated using the direct Fick principle Qc=VO2/(Ca-Cv). Change in peak Qc between first and second iCPETs is measured in L/min.
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak Cardiac Output (Qc)
|
0.2 L/min
Standard Error 0.2
|
-0.2 L/min
Standard Error 0.3
|
1.1 L/min
Standard Error 0.4
|
SECONDARY outcome
Timeframe: First iCPET up to 30 min, 50 minutes rest, second iCPET up to 30 minutesPopulation: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Peak versus rest change in cardiac output expressed in L/min between first and second iCPETs. Cardiac output is determined using the direct Fick principle.
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak-Rest Cardiac Output (Qc)
|
-0.2 L/min
Standard Error 0.6
|
-1.9 L/min
Standard Error 0.6
|
0.9 L/min
Standard Error 0.8
|
SECONDARY outcome
Timeframe: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in peak RAP between first and second iCPETs measured in mmHg.
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak Right Atrial Pressure (RAP)
|
1.2 mm Hg
Standard Error 0.3
|
0.1 mm Hg
Standard Error 0.5
|
1.7 mm Hg
Standard Error 0.7
|
SECONDARY outcome
Timeframe: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Peak versus rest changes in RAP between first and second iCPETs measured in mmHg
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak-Rest Right Atrial Pressure (RAP)
|
1.0 mm Hg
Standard Error 0.5
|
-0.6 mm Hg
Standard Error 0.5
|
0.0 mm Hg
Standard Error 1.0
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in peak PAWP between first and second iCPETs measured in mmHg
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak Pulmonary Arterial Wedge Pressure (PAWP)
|
1.0 mm Hg
Standard Error 0.8
|
1.0 mm Hg
Standard Error 0.5
|
1.5 mm Hg
Standard Error 1.4
|
SECONDARY outcome
Timeframe: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in peak SV between first and second iCPETs measured in mL
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak Stroke Volume (SV)
|
3.0 mL
Standard Error 1.4
|
-1.1 mL
Standard Error 1.9
|
-12.7 mL
Standard Error 12.9
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in peak arterial-venous oxygen content difference normalized to hemoglobin (Ca-vO2)/\[Hgb\] between first and second iCPETs
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=5 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Peak (Ca-vO2)/[Hgb]
|
0.0 Ratio
Standard Error 0.0
|
0.0 Ratio
Standard Error 0.0
|
0.0 Ratio
Standard Error 0.1
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in ventilatory efficiency between first and second iCPETs
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Ventilatory Efficiency (VE/VCO2)
|
-0.2 Ratio
Standard Error 0.8
|
1.0 Ratio
Standard Error 0.6
|
1.7 Ratio
Standard Error 0.6
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in perception of fatigue at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Borg Fatigue Scale
|
0.1 units on a scale
Standard Error 0.2
|
-0.6 units on a scale
Standard Error 0.3
|
0.4 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.Population: Data was collected for all 45 patient, 23 females on study drug, 22 on placebo (16 females, 6 males).
Difference in perceived dyspnea at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).
Outcome measures
| Measure |
Study Drug - Pyridostigmine
n=23 Participants
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo (Female)
n=16 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
|
Placebo (Male)
n=6 Participants
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Not included in statistical analysis
|
|---|---|---|---|
|
Borg Dyspnea Scale
|
-0.1 units on a scale
Standard Error 0.2
|
-1.0 units on a scale
Standard Error 0.5
|
0.3 units on a scale
Standard Error 0.5
|
Adverse Events
Study Drug - Pyridostigmine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Drug - Pyridostigmine
n=23 participants at risk
Pyridostigmine 60 mg by mouth as a one time dose
Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
|
Placebo
n=22 participants at risk
Placebo by mouth as a one time dose
Placebo: Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
Deaths and Adverse Events for the Placebo Arm were collected together regardless of sex
|
|---|---|---|
|
Immune system disorders
Post-Exertional Malaise (PEM)
|
56.5%
13/23 • Adverse events were monitored during the two iCPETs and for the duration of the 50 minutes rest between the two iCPETs. After the second iCPET, the subjects were monitored for an hour in the recovery room. The subjects received a follow up phone call or email up to one week following the day of the procedure to assess if they experienced any adverse events from the study. This was documented for every patient.
Collection of adverse events after subject had been discharged from the site was based on a follow-up phone call or email up to one week following the day of the iCPET.
|
50.0%
11/22 • Adverse events were monitored during the two iCPETs and for the duration of the 50 minutes rest between the two iCPETs. After the second iCPET, the subjects were monitored for an hour in the recovery room. The subjects received a follow up phone call or email up to one week following the day of the procedure to assess if they experienced any adverse events from the study. This was documented for every patient.
Collection of adverse events after subject had been discharged from the site was based on a follow-up phone call or email up to one week following the day of the iCPET.
|
|
Skin and subcutaneous tissue disorders
Wrist Pain
|
8.7%
2/23 • Adverse events were monitored during the two iCPETs and for the duration of the 50 minutes rest between the two iCPETs. After the second iCPET, the subjects were monitored for an hour in the recovery room. The subjects received a follow up phone call or email up to one week following the day of the procedure to assess if they experienced any adverse events from the study. This was documented for every patient.
Collection of adverse events after subject had been discharged from the site was based on a follow-up phone call or email up to one week following the day of the iCPET.
|
18.2%
4/22 • Adverse events were monitored during the two iCPETs and for the duration of the 50 minutes rest between the two iCPETs. After the second iCPET, the subjects were monitored for an hour in the recovery room. The subjects received a follow up phone call or email up to one week following the day of the procedure to assess if they experienced any adverse events from the study. This was documented for every patient.
Collection of adverse events after subject had been discharged from the site was based on a follow-up phone call or email up to one week following the day of the iCPET.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place