Trial Outcomes & Findings for Augmenting Effects of L-DOPS With Carbidopa and Entacapone (NCT NCT00547911)
NCT ID: NCT00547911
Last Updated: 2014-07-17
Results Overview
Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to 48 hours after receiving drug(s)
Results posted on
2014-07-17
Participant Flow
Participant milestones
| Measure |
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
|
LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
|
LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
|
LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
|
LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
|
LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
|
LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
|
LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
|
LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
|
LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
|
LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Augmenting Effects of L-DOPS With Carbidopa and Entacapone
Baseline characteristics by cohort
| Measure |
Healthy Volunteer
n=2 Participants
Subjects in good general health
|
Pure Autonomic Failure
n=7 Participants
Subjects with Pure Autonomic Failure
|
Multiple System Atrophy
n=2 Participants
Subjects with autonomic failure and a history of Multiple System Atrophy
|
Parkinson's Disease
n=3 Participants
Subjects with autonomic failure and a history of Parkinson's Disease
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
68.6 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
57.0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
64.0 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
0 nmol/L
Standard Error 0
|
0.003 nmol/L
Standard Error 0.003
|
0.897 nmol/L
Standard Error 0.753
|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
2246 nmol/L
Standard Error 611
|
1731 nmol/L
Standard Error 440
|
2068 nmol/L
Standard Error 413
|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
7067 nmol/L
Standard Error 1955
|
7077 nmol/L
Standard Error 1324
|
9114 nmol/L
Standard Error 1962
|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
8695 nmol/L
Standard Error 1659
|
9059 nmol/L
Standard Error 1447
|
12008 nmol/L
Standard Error 2294
|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
6843 nmol/L
Standard Error 1080
|
7242 nmol/L
Standard Error 1749
|
7172 nmol/L
Standard Error 891
|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
211 nmol/L
Standard Error 103
|
188 nmol/L
Standard Error 51
|
331 nmol/L
Standard Error 203
|
|
Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
48 Hour
|
8 nmol/L
Standard Error 4
|
7 nmol/L
Standard Error 2
|
6 nmol/L
Standard Error 1
|
PRIMARY outcome
Timeframe: Up to 48 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
0.87 nmol/L
Standard Error 0.19
|
0.85 nmol/L
Standard Error 0.15
|
1.08 nmol/L
Standard Error 0.23
|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
0.89 nmol/L
Standard Error 0.14
|
0.87 nmol/L
Standard Error 0.16
|
1.06 nmol/L
Standard Error 0.16
|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
1.17 nmol/L
Standard Error 0.15
|
0.98 nmol/L
Standard Error 0.19
|
1.49 nmol/L
Standard Error 0.16
|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
1.27 nmol/L
Standard Error 0.15
|
1.12 nmol/L
Standard Error 0.19
|
1.69 nmol/L
Standard Error 0.16
|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
1.26 nmol/L
Standard Error 0.18
|
0.98 nmol/L
Standard Error 0.19
|
1.62 nmol/L
Standard Error 0.13
|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
0.85 nmol/L
Standard Error 0.16
|
0.89 nmol/L
Standard Error 0.15
|
1.09 nmol/L
Standard Error 0.19
|
|
Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
48 Hour
|
0.70 nmol/L
Standard Error 0.13
|
0.85 nmol/L
Standard Error 0.16
|
0.84 nmol/L
Standard Error 0.15
|
PRIMARY outcome
Timeframe: Up to 48 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=9 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=11 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
15.7 nmol/L
Standard Error 4.3
|
1.74 nmol/L
Standard Error 0.33
|
33.03 nmol/L
Standard Error 10.91
|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
48 Hour
|
0.9 nmol/L
Standard Error 0.4
|
3.00 nmol/L
Standard Error 0.58
|
0.90 nmol/L
Standard Error 0.47
|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
0.1 nmol/L
Standard Error 0.1
|
1.66 nmol/L
Standard Error 0.48
|
0.97 nmol/L
Standard Error 0.40
|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
4.0 nmol/L
Standard Error 1.0
|
2.54 nmol/L
Standard Error 0.49
|
4.58 nmol/L
Standard Error 1.37
|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
10.1 nmol/L
Standard Error 5.7
|
1.52 nmol/L
Standard Error 0.49
|
15.04 nmol/L
Standard Error 3.76
|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
11.0 nmol/L
Standard Error 5.1
|
1.70 nmol/L
Standard Error 0.28
|
19.91 nmol/L
Standard Error 4.59
|
|
Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
1.4 nmol/L
Standard Error 0.8
|
3.24 nmol/L
Standard Error 0.54
|
2.21 nmol/L
Standard Error 1.11
|
PRIMARY outcome
Timeframe: Up to 48 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
3.4 nmol/L
Standard Error 0.4
|
3.4 nmol/L
Standard Error 0.4
|
3.5 nmol/L
Standard Error 0.3
|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
4.1 nmol/L
Standard Error 0.6
|
3.5 nmol/L
Standard Error 0.4
|
8.0 nmol/L
Standard Error 1.2
|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
5.4 nmol/L
Standard Error 0.9
|
3.3 nmol/L
Standard Error 0.5
|
16.6 nmol/L
Standard Error 2.3
|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
6.1 nmol/L
Standard Error 0.8
|
3.6 nmol/L
Standard Error 0.6
|
19.3 nmol/L
Standard Error 3.2
|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
5.7 nmol/L
Standard Error 0.8
|
3.5 nmol/L
Standard Error 0.8
|
10.7 nmol/L
Standard Error 1.6
|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
3.4 nmol/L
Standard Error 0.5
|
3.8 nmol/L
Standard Error 0.4
|
4.1 nmol/L
Standard Error 0.4
|
|
Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
48 Hour
|
3.4 nmol/L
Standard Error 0.4
|
3.7 nmol/L
Standard Error 0.5
|
3.8 nmol/L
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Up to 24 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
140 mmHg
Standard Error 7
|
143 mmHg
Standard Error 6
|
139 mmHg
Standard Error 5
|
|
Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
148 mmHg
Standard Error 8
|
144 mmHg
Standard Error 7
|
149 mmHg
Standard Error 8
|
|
Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
163 mmHg
Standard Error 10
|
144 mmHg
Standard Error 11
|
158 mmHg
Standard Error 10
|
|
Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
165 mmHg
Standard Error 10
|
148 mmHg
Standard Error 8
|
161 mmHg
Standard Error 12
|
|
Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
161 mmHg
Standard Error 9
|
146 mmHg
Standard Error 8
|
159 mmHg
Standard Error 9
|
|
Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
149 mmHg
Standard Error 7
|
143 mmHg
Standard Error 6
|
144 mmHg
Standard Error 7
|
SECONDARY outcome
Timeframe: Up to 24 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
80 mmHg
Standard Error 4
|
81 mmHg
Standard Error 4
|
78 mmHg
Standard Error 4
|
|
Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
85 mmHg
Standard Error 5
|
80 mmHg
Standard Error 5
|
85 mmHg
Standard Error 5
|
|
Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
86 mmHg
Standard Error 6
|
81 mmHg
Standard Error 6
|
91 mmHg
Standard Error 5
|
|
Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
88 mmHg
Standard Error 7
|
84 mmHg
Standard Error 5
|
91 mmHg
Standard Error 6
|
|
Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
89 mmHg
Standard Error 5
|
82 mmHg
Standard Error 5
|
89 mmHg
Standard Error 5
|
|
Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
84 mmHg
Standard Error 3
|
81 mmHg
Standard Error 4
|
81 mmHg
Standard Error 3
|
SECONDARY outcome
Timeframe: Up to 24 hours after receiving drug(s)Population: Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the "Limitations and Caveats" section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.
Outcome measures
| Measure |
LDOPS + Placebo
n=13 Participants
Orally received 400 mg of droxidopa after 200 mg of placebo
|
LDOPS + CAR
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of carbidopa
|
LDOPS + ENT
n=14 Participants
Orally received 400 mg of droxidopa after 200 mg of entacapone
|
|---|---|---|---|
|
Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
24 Hour
|
66 BPM
Standard Error 3
|
66 BPM
Standard Error 3
|
68 BPM
Standard Error 4
|
|
Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Baseline
|
67 BPM
Standard Error 3
|
66 BPM
Standard Error 3
|
67 BPM
Standard Error 3
|
|
Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
1 Hour
|
65 BPM
Standard Error 3
|
68 BPM
Standard Error 4
|
65 BPM
Standard Error 2
|
|
Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
2 Hour
|
66 BPM
Standard Error 3
|
65 BPM
Standard Error 3
|
65 BPM
Standard Error 3
|
|
Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
3 Hour
|
68 BPM
Standard Error 4
|
64 BPM
Standard Error 3
|
64 BPM
Standard Error 3
|
|
Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
6 Hour
|
67 BPM
Standard Error 4
|
62 BPM
Standard Error 2
|
67 BPM
Standard Error 2
|
Adverse Events
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT
n=2 participants at risk
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
|
LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR
n=2 participants at risk
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
|
LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT
n=2 participants at risk
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
|
LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo
n=2 participants at risk
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
|
LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR
n=3 participants at risk
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
|
LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
n=3 participants at risk
There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject's systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis followed by Pulmonary Embolism
|
0.00%
0/2 • Duration of the study
|
0.00%
0/2 • Duration of the study
|
0.00%
0/2 • Duration of the study
|
50.0%
1/2 • Duration of the study
|
0.00%
0/3 • Duration of the study
|
0.00%
0/3 • Duration of the study
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place