Trial Outcomes & Findings for A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa (NCT NCT00782340)
NCT ID: NCT00782340
Last Updated: 2014-05-16
Results Overview
The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. For the change from randomization, negative numbers represent improvement from randomization in OHQ score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
263 participants
Primary outcome timeframe
7 days
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
Open-Label Titration
All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
|
Droxidopa
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|---|
|
Open Label Titration
STARTED
|
263
|
0
|
0
|
|
Open Label Titration
COMPLETED
|
162
|
0
|
0
|
|
Open Label Titration
NOT COMPLETED
|
101
|
0
|
0
|
|
Randomized Double Blind
STARTED
|
0
|
82
|
80
|
|
Randomized Double Blind
COMPLETED
|
0
|
82
|
80
|
|
Randomized Double Blind
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Open-Label Titration
All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
|
Droxidopa
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|---|
|
Open Label Titration
Adverse Event
|
12
|
0
|
0
|
|
Open Label Titration
Treatment failure
|
50
|
0
|
0
|
|
Open Label Titration
Protocol Violation
|
5
|
0
|
0
|
|
Open Label Titration
Withdrawal by Subject
|
5
|
0
|
0
|
|
Open Label Titration
Enrollment capped
|
16
|
0
|
0
|
|
Open Label Titration
Did not meet responder criteria
|
2
|
0
|
0
|
|
Open Label Titration
Lost to Follow-up
|
5
|
0
|
0
|
|
Open Label Titration
Randomized in error
|
6
|
0
|
0
|
Baseline Characteristics
A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa
Baseline characteristics by cohort
| Measure |
Not Randomized
n=101 Participants
Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.
|
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 16.90 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 20.03 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 17.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
33 participants
n=7 Participants
|
32 participants
n=5 Participants
|
113 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
44 participants
n=5 Participants
|
143 participants
n=4 Participants
|
|
Primary Clinical Diagnosis
Parkinson's Disease
|
45 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
111 participants
n=4 Participants
|
|
Primary Clinical Diagnosis
Multiple System Atrophy
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
11 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Primary Clinical Diagnosis
Pure Autonomic Failure
|
33 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
87 participants
n=4 Participants
|
|
Primary Clinical Diagnosis
Non-Diabetic Autonomic Neuropathy
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Primary Clinical Diagnosis
Other Diagnosis
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Missing data are imputed using the last observation carried forward method.
The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. For the change from randomization, negative numbers represent improvement from randomization in OHQ score.
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Orthostatic Hypotension Questionnaire Score (OHQ)
|
-1.83 units on a scale
Standard Deviation 2.067
|
-0.93 units on a scale
Standard Deviation 1.691
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Missing data are imputed using the last observation carried forward method.
OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Outcome measures
| Measure |
Droxidopa
n=81 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=79 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)
|
-1.98 units on a scale
Standard Deviation 2.310
|
-0.92 units on a scale
Standard Deviation 1.816
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Missing data are imputed using the last observation carried forward method.
OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Outcome measures
| Measure |
Droxidopa
n=81 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=79 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score
|
-1.68 units on a scale
Standard Deviation 2.125
|
-0.95 units on a scale
Standard Deviation 1.901
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Missing data are imputed using the last observation carried forward method.
OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Activities Involving Standing a Short Time (OHDAS Item 1)
|
-1.9 units on a scale
Standard Deviation 2.75
|
-0.8 units on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Missing data are imputed using the last observation carried forward method.
OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Activities Involving Walking a Short Time (OHDAS Item 3)
|
-1.7 units on a scale
Standard Deviation 2.55
|
-0.6 units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Missing data are imputed using the last observation carried forward method.
OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
|
-2.4 units on a scale
Standard Deviation 3.20
|
-1.1 units on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: 7 daysThe CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows; Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7).
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Patient-Reported Clinical Global Improvement - Severity Scores
Normal-Borderline OH
|
23 participants
|
16 participants
|
|
Patient-Reported Clinical Global Improvement - Severity Scores
Mild-Moderate OH
|
39 participants
|
47 participants
|
|
Patient-Reported Clinical Global Improvement - Severity Scores
Marked OH-Most ill with OH
|
20 participants
|
17 participants
|
SECONDARY outcome
Timeframe: 7 daysThe CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows; Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7).
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=80 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Clinician-Reported Clinical Global Improvement - Severity Scores
Normal-Borderline OH
|
21 participants
|
15 participants
|
|
Clinician-Reported Clinical Global Improvement - Severity Scores
Mild-Moderate OH
|
39 participants
|
44 participants
|
|
Clinician-Reported Clinical Global Improvement - Severity Scores
Marked OH-Most ill with OH
|
22 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 7 daysChange: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Outcome measures
| Measure |
Droxidopa
n=82 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=79 Participants
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing
|
11.2 mmHg
Standard Deviation 22.89
|
3.9 mmHg
Standard Deviation 16.28
|
Adverse Events
Open-Label Titration
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Droxidopa
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-Label Titration
n=263 participants at risk
All patients treated with study drug during dose titration (7-14 days)
|
Droxidopa
n=81 participants at risk
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=81 participants at risk
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.38%
1/263 • Number of events 1
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
1/263 • Number of events 1
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
|
Infections and infestations
Urinary Tract Infection
|
0.38%
1/263 • Number of events 1
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.38%
1/263 • Number of events 1
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.38%
1/263 • Number of events 1
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
Other adverse events
| Measure |
Open-Label Titration
n=263 participants at risk
All patients treated with study drug during dose titration (7-14 days)
|
Droxidopa
n=81 participants at risk
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=81 participants at risk
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
9.9%
26/263 • Number of events 34
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
7.4%
6/81 • Number of events 7
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
0.00%
0/81
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
|
Nervous system disorders
Dizziness
|
6.5%
17/263 • Number of events 18
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
3.7%
3/81 • Number of events 3
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
1.2%
1/81 • Number of events 1
One patient randomized to the droxidopa group in the randomized double blind phase was treated with placebo during this period and is included in the placebo group (actual treatment received) for the safety analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60