Trial Outcomes & Findings for The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury (NCT NCT02893553)
NCT ID: NCT02893553
Last Updated: 2024-10-01
Results Overview
Seated systolic blood pressure following intervention administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
4 hours
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
Study 1
Study 1 is a dose escalation, single blinded, trial to determine the individualized dose of each of 3 medications (midodrine, pyridostigmine, mirabegron) that increases systolic blood pressure (SBP) into the normal range (111-139 mmHg).
Midodrine: 5 mg (Low), 10 mg (Medium), 15 mg (High) Mirabegron: 25 mg (Low), 50 mg (Medium), 75 mg (High) Pyridostigmine: 60 mg (Low), 90 mg (Medium), 120 mg (High) Within this dose escalation trial, each participant will be started on the lowest dose of each of the three medications, and may receive the medium or high dose depending on their SBP response.
Study 2 is a randomized, placebo-controlled, double-blinded investigation to determine the effects of the normalization of SBP on cerebral blood flow, cognitive function, and quality of life. In study 2 participants will receive the dose of each medication that normalized their SBP in study 1.
Midodrine: 5 mg (Low), 10 mg (Medium), 15 mg (High) Mirabegron: 25 mg (Low), 50 mg (Medium), 75 mg (High) Pyridostigmine: 60 mg (Low), 90 mg (Medium), 120 mg (High) Placebo In study 2 all participants will receive one dose (optimized for their SBP response) of each medication and placebo.
|
|---|---|
|
Study 1
STARTED
|
21
|
|
Study 1
Midodrine (Low)
|
19
|
|
Study 1
Midodrine (Medium)
|
6
|
|
Study 1
Midodrine (High)
|
0
|
|
Study 1
Mirabegron (Low)
|
19
|
|
Study 1
Mirabegron (Medium)
|
15
|
|
Study 1
Mirabegron (High)
|
8
|
|
Study 1
Pyridostigmine (Low)
|
19
|
|
Study 1
Pyridostigmine (Medium)
|
10
|
|
Study 1
Pyridostigmine (High)
|
5
|
|
Study 1
Placebo
|
0
|
|
Study 1
COMPLETED
|
19
|
|
Study 1
NOT COMPLETED
|
2
|
|
Study 2
STARTED
|
18
|
|
Study 2
Midodrine (Low)
|
11
|
|
Study 2
Midodrine (Medium)
|
5
|
|
Study 2
Midodrine (High)
|
0
|
|
Study 2
Mirabegron (Low)
|
3
|
|
Study 2
Mirabegron (Medium)
|
7
|
|
Study 2
Mirabegron (High)
|
7
|
|
Study 2
Pyridostigmine (Low)
|
7
|
|
Study 2
Pyridostigmine (Medium)
|
5
|
|
Study 2
Pyridostigmine (High)
|
5
|
|
Study 2
Placebo
|
16
|
|
Study 2
COMPLETED
|
16
|
|
Study 2
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Study 1
n=21 Participants
Study 1 is a dose escalation, single blinded, trial to determine the individualized dose of each of 3 medications (midodrine, pyridostigmine, mirabegron) that increases systolic blood pressure (SBP) into the normal range (111-139 mmHg).
Midodrine: 5 mg (Low), 10 mg (Medium), 15 mg (High) Mirabegron: 25 mg (Low), 50 mg (Medium), 75 mg (High) Pyridostigmine: 60 mg (Low), 90 mg (Medium), 120 mg (High) Within this dose escalation trial, each participant will be started on the lowest dose of each of the three medications, and may receive the medium or high dose depending on their SBP response.
Study 2 is a randomized, placebo-controlled, double-blinded investigation to determine the effects of the normalization of SBP on cerebral blood flow, cognitive function, and quality of life. In study 2 participants will receive the dose of each medication that normalized their SBP in study 1.
Midodrine: 5 mg (Low), 10 mg (Medium), 15 mg (High) Mirabegron: 25 mg (Low), 50 mg (Medium), 75 mg (High) Pyridostigmine: 60 mg (Low), 90 mg (Medium), 120 mg (High) Placebo In study 2 all participants will receive one dose (optimized for their SBP response) of each medication and placebo.
Mirabegron: 25 mg (Low), 50 mg (Medium), 75 mg (High) Pyridostigmine: 60 mg (Low), 90 mg (Medium), 120 mg (High)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.47 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Means are compared between medications and placebo of study 2, regardless of dose, as pre-specified in the study protocol.
Seated systolic blood pressure following intervention administration.
Outcome measures
| Measure |
Study 2: Placebo
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
Study 2: Midodrine
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
Study 2: Mirabegron
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
Study 2: Pyridostigmine
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
93.21 mmHg
Standard Deviation 9.01
|
107.00 mmHg
Standard Deviation 11.07
|
95.8 mmHg
Standard Deviation 9.5
|
93.84 mmHg
Standard Deviation 9.69
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Data are compared between medications and placebo of study 2, regardless of dose, as pre-specified in the study protocol.
Number of participants with a systolic blood pressure readings between 111-139 mmHg in response to each of the four conditions: 1. Placebo 2. Midodrine 3. Mirabegron 4. Pyridostigmine
Outcome measures
| Measure |
Study 2: Placebo
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
Study 2: Midodrine
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
Study 2: Mirabegron
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
Study 2: Pyridostigmine
n=16 Participants
Study 2 is a blinded comparison of the seated systolic blood pressure responses to Midodrine Hydrochloride, Pyridostigmine Bromide, and Mirabegron compared to placebo in a randomized, double-blinded, placebo-control trial.
|
|---|---|---|---|---|
|
Number of Participants With Normal Blood Pressure Readings
|
4 Participants
|
14 Participants
|
6 Participants
|
5 Participants
|
Adverse Events
Midodrine (Low)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midodrine (Mid)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midodrine (High)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mirabegron (Low)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mirabegron (Mid)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mirabegron (hi)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pyridostigmine (Low)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pyridostigmine (Mid)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pyridostigmine (hi)
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place