Trial Outcomes & Findings for Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury (NCT NCT02307565)
NCT ID: NCT02307565
Last Updated: 2025-02-21
Results Overview
Seated systolic blood pressure following midodrine administration compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
30 days
Results posted on
2025-02-21
Participant Flow
Number of participants eligible for study was only 19.
Participant milestones
| Measure |
Midodrine/Placebo
Arm 1 last 30 days. Subject will either be given midodrine or placebo to take during Arm 1.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
Placebo/Midodrine
Arm 2 lasts 30 days after a 14 day washout following Arm 1. Subject will be given a drug (placebo or midodrine) to take during Arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Midodrine/Placebo
Arm 1 last 30 days. Subject will either be given midodrine or placebo to take during Arm 1.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
Placebo/Midodrine
Arm 2 lasts 30 days after a 14 day washout following Arm 1. Subject will be given a drug (placebo or midodrine) to take during Arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Midodrine/Placebo
n=8 Participants
Arm 1 last 30 days. Subject will be given midodrine during arm 1 and placebo during arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
Placebo/Midodrine
n=11 Participants
Arm 2 last 30 days. Subject will be given placebo during arm 1 and midodrine during arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysSeated systolic blood pressure following midodrine administration compared to placebo.
Outcome measures
| Measure |
Midodrine
n=19 Participants
30 days of midodrine
|
Placebo
n=12 Participants
Arm 2 lasts 30 days after a 14 day washout following Arm 1. Subject will be given a drug (placebo or midodrine) to take during Arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
|---|---|---|
|
Systolic Blood Pressure
|
116.3 mmHg
Standard Deviation 22.7
|
98.0 mmHg
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: 30 daysMiddle cerebral artery blood flow velocity following midodrine administration compared to placebo.
Outcome measures
| Measure |
Midodrine
n=19 Participants
30 days of midodrine
|
Placebo
n=12 Participants
Arm 2 lasts 30 days after a 14 day washout following Arm 1. Subject will be given a drug (placebo or midodrine) to take during Arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
|---|---|---|
|
Cerebral Blood Flow
|
45.08 cm/sec
Standard Deviation 12.87
|
43.97 cm/sec
Standard Deviation 16.70
|
SECONDARY outcome
Timeframe: 30 daysMemory score on the Hopkins Verbal Learning Test following midodrine administration compared to placebo. Higher score is better, range from 0 to 36.
Outcome measures
| Measure |
Midodrine
n=19 Participants
30 days of midodrine
|
Placebo
n=12 Participants
Arm 2 lasts 30 days after a 14 day washout following Arm 1. Subject will be given a drug (placebo or midodrine) to take during Arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
|---|---|---|
|
Hopkins Verbal Learning Test
|
-3.56 score on a scale
Standard Deviation 4.16
|
-2.27 score on a scale
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: 30 daysNumber of daily systolic blood pressure recordings above 140 mmHg following midodrine administration compared to placebo.
Outcome measures
| Measure |
Midodrine
n=891 blood pressure recordings
30 days of midodrine
|
Placebo
n=1070 blood pressure recordings
Arm 2 lasts 30 days after a 14 day washout following Arm 1. Subject will be given a drug (placebo or midodrine) to take during Arm 2.
Midodrine: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Placebo: Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
|
|---|---|---|
|
Number of Hypertensive Events
|
112 blood pressure recordings
|
50 blood pressure recordings
|
Adverse Events
Midodrine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midodrine
n=19 participants at risk
30 days of midodrine administration
|
Placebo
n=19 participants at risk
30 days of placebo administration
|
|---|---|---|
|
Vascular disorders
Hypertensive response
|
15.8%
3/19 • Number of events 3 • 30 days
Risk of SAE is not greater than expected for the population. Risk of all-cause mortality is not greater than expected for the population.
|
0.00%
0/19 • 30 days
Risk of SAE is not greater than expected for the population. Risk of all-cause mortality is not greater than expected for the population.
|
|
Renal and urinary disorders
UTI
|
5.3%
1/19 • Number of events 1 • 30 days
Risk of SAE is not greater than expected for the population. Risk of all-cause mortality is not greater than expected for the population.
|
0.00%
0/19 • 30 days
Risk of SAE is not greater than expected for the population. Risk of all-cause mortality is not greater than expected for the population.
|
|
Renal and urinary disorders
Constipation
|
5.3%
1/19 • Number of events 1 • 30 days
Risk of SAE is not greater than expected for the population. Risk of all-cause mortality is not greater than expected for the population.
|
0.00%
0/19 • 30 days
Risk of SAE is not greater than expected for the population. Risk of all-cause mortality is not greater than expected for the population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place