Trial Outcomes & Findings for Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI (NCT NCT02307526)
NCT ID: NCT02307526
Last Updated: 2017-07-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Average systolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.
Results posted on
2017-07-21
Participant Flow
Participant milestones
| Measure |
Spinal Cord Injury
10 individuals with spinal cord injury (SCI: C4-C7) were recruited.
|
|---|---|
|
Day 1 - No Drug
STARTED
|
10
|
|
Day 1 - No Drug
COMPLETED
|
10
|
|
Day 1 - No Drug
NOT COMPLETED
|
0
|
|
Day 2 - 60 mg of Pyridostigmine
STARTED
|
10
|
|
Day 2 - 60 mg of Pyridostigmine
COMPLETED
|
10
|
|
Day 2 - 60 mg of Pyridostigmine
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI
Baseline characteristics by cohort
| Measure |
Spinal Cord Injury
n=10 Participants
Ten individuals with SCI (C4-C7) were recruited.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average systolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.Outcome measures
| Measure |
Pyridostigmine Bromide
n=10 Participants
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
|
NO Drug
n=10 Participants
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
|
|---|---|---|
|
Systolic Blood Pressure
Supine Systolic Blood Pressure
|
97 mm Hg
Standard Deviation 11
|
103 mm Hg
Standard Deviation 14
|
|
Systolic Blood Pressure
45 degree Head-up Tilt Systolic Blood Pressure
|
90 mm Hg
Standard Deviation 18
|
88 mm Hg
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Average diastolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.Outcome measures
| Measure |
Pyridostigmine Bromide
n=10 Participants
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
|
NO Drug
n=10 Participants
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
|
|---|---|---|
|
Diastolic Blood Pressure
Supine Diastolic Blood Pressure
|
64 mm Hg
Standard Deviation 6
|
66 mm Hg
Standard Deviation 10
|
|
Diastolic Blood Pressure
45 degree Head-up Tilt Diastolic Blood Pressure
|
64 mm Hg
Standard Deviation 11
|
63 mm Hg
Standard Deviation 7
|
PRIMARY outcome
Timeframe: Average heart rate of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees following pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.Outcome measures
| Measure |
Pyridostigmine Bromide
n=10 Participants
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
|
NO Drug
n=10 Participants
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
|
|---|---|---|
|
Heart Rate
Supine Heart Rate
|
52 bpm
Standard Deviation 6
|
55 bpm
Standard Deviation 10
|
|
Heart Rate
45 degree Head-up Tilt Heart Rate
|
66 bpm
Standard Deviation 12
|
72 bpm
Standard Deviation 13
|
Adverse Events
Day 1 - No Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Day 2 - Pyridostigmine Bromide
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Day 1 - No Drug
n=10 participants at risk
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
|
Day 2 - Pyridostigmine Bromide
n=10 participants at risk
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide 60 mg will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
|
|---|---|---|
|
Nervous system disorders
Drug Side Effect
|
0.00%
0/10 • 80 minuets after pyridostigmine administration to 200 minuets after pyridostigmine administration.
|
10.0%
1/10 • Number of events 1 • 80 minuets after pyridostigmine administration to 200 minuets after pyridostigmine administration.
|
|
Nervous system disorders
Overheating
|
0.00%
0/10 • 80 minuets after pyridostigmine administration to 200 minuets after pyridostigmine administration.
|
10.0%
1/10 • Number of events 1 • 80 minuets after pyridostigmine administration to 200 minuets after pyridostigmine administration.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place