Trial Outcomes & Findings for Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (NCT NCT00738062)
NCT ID: NCT00738062
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. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
14 days
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
Open-Label Droxidopa
3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
|
Double-blind Droxidopa
Double-blind
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
|
Double-blind Placebo
Double-blind
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 Treatment
STARTED
|
103
|
0
|
0
|
|
Open Label Treatment
COMPLETED
|
75
|
0
|
0
|
|
Open Label Treatment
NOT COMPLETED
|
28
|
0
|
0
|
|
2 Week Randomized Withdrawal
STARTED
|
0
|
38
|
37
|
|
2 Week Randomized Withdrawal
COMPLETED
|
0
|
38
|
37
|
|
2 Week Randomized Withdrawal
NOT COMPLETED
|
0
|
0
|
0
|
|
Open-Label Extension
STARTED
|
74
|
0
|
0
|
|
Open-Label Extension
COMPLETED
|
57
|
0
|
0
|
|
Open-Label Extension
NOT COMPLETED
|
17
|
0
|
0
|
Reasons for withdrawal
| Measure |
Open-Label Droxidopa
3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
|
Double-blind Droxidopa
Double-blind
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
|
Double-blind Placebo
Double-blind
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 Treatment
Lack of Efficacy
|
5
|
0
|
0
|
|
Open Label Treatment
Adverse Event
|
11
|
0
|
0
|
|
Open Label Treatment
Protocol Violation
|
2
|
0
|
0
|
|
Open Label Treatment
Withdrawal by Subject
|
9
|
0
|
0
|
|
Open Label Treatment
Investigator Decision
|
1
|
0
|
0
|
|
Open-Label Extension
Adverse Event
|
5
|
0
|
0
|
|
Open-Label Extension
Physician Decision
|
1
|
0
|
0
|
|
Open-Label Extension
Lack of Efficacy
|
2
|
0
|
0
|
|
Open-Label Extension
Withdrawal by Subject
|
6
|
0
|
0
|
|
Open-Label Extension
Protocol Violation
|
1
|
0
|
0
|
|
Open-Label Extension
Study Terminated
|
2
|
0
|
0
|
Baseline Characteristics
Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
Baseline characteristics by cohort
| Measure |
Open-Label Droxidopa
n=27 Participants
Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
|
Double-blind Droxidopa
n=38 Participants
Double-blind
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
|
Double-blind Placebo
n=37 Participants
Double-blind
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=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.95 • n=99 Participants
|
68.2 years
STANDARD_DEVIATION 13.03 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 12.09 • n=206 Participants
|
65.8 years
STANDARD_DEVIATION 12.31 • n=7 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
25 participants
n=107 Participants
|
22 participants
n=206 Participants
|
63 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=99 Participants
|
6 participants
n=107 Participants
|
3 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
New Zealand
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Parkinson's Disease
|
10 participants
n=99 Participants
|
20 participants
n=107 Participants
|
18 participants
n=206 Participants
|
48 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Multiple System Atrophy
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
9 participants
n=206 Participants
|
27 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Pure Autonomic Failure
|
3 participants
n=99 Participants
|
8 participants
n=107 Participants
|
7 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Dopamine Beta-Hydroxylase Deficiency
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Non-Diabetic Autonomic Neuropathy
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study. One droxidopa patient was excluded from the analysis because OHQ values were not evaluable.
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. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization.
Outcome measures
| Measure |
Droxidopa
n=37 Participants
Study medication
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=37 Participants
Placebo
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 Composite Score (OHQ)
|
0.57 units on a scale
Standard Deviation 1.891
|
0.90 units on a scale
Standard Deviation 1.550
|
SECONDARY outcome
Timeframe: 14 daysPopulation: One droxidopa patient excluded from analysis because data were not evaluable.
The OHDAS 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 asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug).
Outcome measures
| Measure |
Droxidopa
n=37 Participants
Study medication
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=37 Participants
Placebo
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 Daily Activities (OHDAS) Score
|
0.53 units on a scale
Standard Deviation 2.204
|
0.71 units on a scale
Standard Deviation 1.629
|
SECONDARY outcome
Timeframe: 14 daysThe OHSA 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. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug).
Outcome measures
| Measure |
Droxidopa
n=38 Participants
Study medication
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=37 Participants
Placebo
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
|
0.59 units on a scale
Standard Deviation 1.963
|
1.10 units on a scale
Standard Deviation 1.658
|
SECONDARY outcome
Timeframe: 14 daysChange: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.
Outcome measures
| Measure |
Droxidopa
n=38 Participants
Study medication
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=37 Participants
Placebo
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
|
-8.4 mmHg
Standard Deviation 26.63
|
0.0 mmHg
Standard Deviation 18.51
|
SECONDARY outcome
Timeframe: 14 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=38 Participants
Study medication
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=37 Participants
Placebo
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 Impression - Severity
Normal-Borderline OH
|
13 participants
|
12 participants
|
|
Patient Reported Clinical Global Impression - Severity
Mild-Moderate OH
|
16 participants
|
13 participants
|
|
Patient Reported Clinical Global Impression - Severity
Marked OH-Most ill with OH
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 14 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=38 Participants
Study medication
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=37 Participants
Placebo
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 Recorded Clinical Global Impression - Severity
Normal-Borderline OH
|
9 participants
|
7 participants
|
|
Clinician Recorded Clinical Global Impression - Severity
Mild-Moderate OH
|
16 participants
|
15 participants
|
|
Clinician Recorded Clinical Global Impression - Severity
Marked OH-Most ill with OH
|
13 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 14 daysThe CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation. Patients will be grouped according change in disease as follows; * Very Much Improved to Slightly Improved (CGI-I 1-3), * No Change (CGI-I 4), * Slightly Worse to Very Much Worse (CGI-I 5-7).
Outcome measures
| Measure |
Droxidopa
n=38 Participants
Study medication
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=37 Participants
Placebo
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 Impression - Improvement
Very much - Slightly Improved
|
25 participants
|
20 participants
|
|
Patient Reported Clinical Global Impression - Improvement
No Change
|
7 participants
|
5 participants
|
|
Patient Reported Clinical Global Impression - Improvement
Slightly - Very much Worse
|
6 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 14 daysThe CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation. Patients will be grouped according change in disease as follows; * Very Much Improved to Slightly Improved (CGI-I 1-3), * No Change (CGI-I 4), * Slightly Worse to Very Much Worse (CGI-I 5-7).
Outcome measures
| Measure |
Droxidopa
n=38 Participants
Study medication
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=37 Participants
Placebo
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 Rated Clinical Global Impressions - Improvement
Very much - Slightly Improved
|
26 participants
|
20 participants
|
|
Clinician Rated Clinical Global Impressions - Improvement
No Change
|
4 participants
|
8 participants
|
|
Clinician Rated Clinical Global Impressions - Improvement
Slightly - Very much Worse
|
8 participants
|
9 participants
|
POST_HOC outcome
Timeframe: 14 daysOHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients were on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.
Outcome measures
| Measure |
Droxidopa
n=38 Participants
Study medication
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=37 Participants
Placebo
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)
|
0.9 units on a scale
Standard Deviation 2.39
|
1.3 units on a scale
Standard Deviation 2.21
|
Adverse Events
Three Month Open-Label Droxidopa
Serious events: 12 serious events
Other events: 37 other events
Deaths: 0 deaths
Double-blind Droxidopa
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Double-blind Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Long-Term Follow-up
Serious events: 16 serious events
Other events: 43 other events
Deaths: 0 deaths
Total Droxidopa
Serious events: 26 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Three Month Open-Label Droxidopa
n=102 participants at risk
all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
|
Double-blind Droxidopa
n=38 participants at risk
Double-blind
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
|
Double-blind Placebo
n=37 participants at risk
Double-blind
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
|
Long-Term Follow-up
n=74 participants at risk
Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
|
Total Droxidopa
n=102 participants at risk
All Patients exposed to droxidopa
|
|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.98%
1/102 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
2.7%
2/74 • Number of events 2
|
3.9%
4/102 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Hallucination, visual
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Major depression
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/102
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/102
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/102
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
2.7%
2/74 • Number of events 2
|
2.9%
3/102 • Number of events 3
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
2.0%
2/102 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Surgical and medical procedures
Malignant tumour excision
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Venous thrombosis limb
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
0.00%
0/74
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Sudden cardiac death
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
2.7%
2/74 • Number of events 2
|
2.0%
2/102 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
2.7%
2/74 • Number of events 2
|
2.0%
2/102 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
Other adverse events
| Measure |
Three Month Open-Label Droxidopa
n=102 participants at risk
all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
|
Double-blind Droxidopa
n=38 participants at risk
Double-blind
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
|
Double-blind Placebo
n=37 participants at risk
Double-blind
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
|
Long-Term Follow-up
n=74 participants at risk
Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
|
Total Droxidopa
n=102 participants at risk
All Patients exposed to droxidopa
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.9%
5/102 • Number of events 6
|
2.6%
1/38 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
8.1%
6/74 • Number of events 6
|
12.7%
13/102 • Number of events 15
|
|
Nervous system disorders
Syncope
|
3.9%
4/102 • Number of events 5
|
2.6%
1/38 • Number of events 2
|
0.00%
0/37
|
9.5%
7/74 • Number of events 9
|
9.8%
10/102 • Number of events 17
|
|
Nervous system disorders
Dizziness
|
2.0%
2/102 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
6.8%
5/74 • Number of events 8
|
7.8%
8/102 • Number of events 12
|
|
Nervous system disorders
Tremor
|
2.0%
2/102 • Number of events 2
|
0.00%
0/38
|
0.00%
0/37
|
5.4%
4/74 • Number of events 5
|
4.9%
5/102 • Number of events 7
|
|
Infections and infestations
Urinary Tract Infection
|
8.8%
9/102 • Number of events 10
|
5.3%
2/38 • Number of events 2
|
0.00%
0/37
|
14.9%
11/74 • Number of events 18
|
16.7%
17/102 • Number of events 31
|
|
Infections and infestations
Bacteriuria
|
2.0%
2/102 • Number of events 2
|
0.00%
0/38
|
0.00%
0/37
|
5.4%
4/74 • Number of events 4
|
4.9%
5/102 • Number of events 6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
5.4%
4/74 • Number of events 4
|
4.9%
5/102 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
4/102 • Number of events 4
|
5.3%
2/38 • Number of events 2
|
0.00%
0/37
|
9.5%
7/74 • Number of events 8
|
10.8%
11/102 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.0%
2/102 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
5.4%
4/74 • Number of events 4
|
6.9%
7/102 • Number of events 7
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
7/102 • Number of events 8
|
0.00%
0/38
|
2.7%
1/37 • Number of events 1
|
21.6%
16/74 • Number of events 20
|
19.6%
20/102 • Number of events 29
|
|
Psychiatric disorders
Insomnia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/38
|
0.00%
0/37
|
5.4%
4/74 • Number of events 4
|
4.9%
5/102 • Number of events 5
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
3/102 • Number of events 4
|
0.00%
0/38
|
0.00%
0/37
|
4.1%
3/74 • Number of events 3
|
5.9%
6/102 • Number of events 7
|
|
General disorders
Edema peripheral
|
0.00%
0/102
|
0.00%
0/38
|
0.00%
0/37
|
5.4%
4/74 • Number of events 5
|
3.9%
4/102 • Number of events 5
|
|
Nervous system disorders
Somnolence
|
4.9%
5/102 • Number of events 5
|
0.00%
0/38
|
0.00%
0/37
|
1.4%
1/74 • Number of events 1
|
5.9%
6/102 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.9%
3/102 • Number of events 3
|
0.00%
0/38
|
0.00%
0/37
|
4.1%
3/74 • Number of events 3
|
5.9%
6/102 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60