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Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (NOH303)

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ClinicalTrials.gov Identifier: NCT00738062
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Neurogenic Orthostatic Hypotension
Non-Diabetic Autonomic Neuropathy
Multiple System Atrophy
Dopamine Beta Hydroxylase Deficiency
Interventions Drug: Droxidopa
Drug: Placebo
Enrollment 103

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Droxidopa Double-blind Droxidopa Double-blind Placebo
Hide Arm/Group Description 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)

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: 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

Period Title: Open Label Treatment
Started 103 0 0
Completed 75 0 0
Not Completed 28 0 0
Reason Not Completed
Lack of Efficacy             5             0             0
Adverse Event             11             0             0
Protocol Violation             2             0             0
Withdrawal by Subject             9             0             0
Investigator Decision             1             0             0
Period Title: 2 Week Randomized Withdrawal
Started 0 [1] 38 37
Completed 0 38 37
Not Completed 0 0 0
[1]
Patients completing the open label titration phase were randomized to either Droxidopa or Placebo
Period Title: Open-Label Extension
Started 74 [1] 0 0
Completed 57 0 0
Not Completed 17 0 0
Reason Not Completed
Adverse Event             5             0             0
Physician Decision             1             0             0
Lack of Efficacy             2             0             0
Withdrawal by Subject             6             0             0
Protocol Violation             1             0             0
Study Terminated             2             0             0
[1]
One patient completed double blind randomization but did not enter the open label extension
Arm/Group Title Open-Label Droxidopa Double-blind Droxidopa Double-blind Placebo Total
Hide Arm/Group Description Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)

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: 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 of all reporting groups
Overall Number of Baseline Participants 27 38 37 102
Hide Baseline Analysis Population Description
Omits 1 patient who randomized into the study in error and did not receive study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 38 participants 37 participants 102 participants
61.9  (10.95) 68.2  (13.03) 66.2  (12.09) 65.8  (12.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 38 participants 37 participants 102 participants
Female
13
  48.1%
15
  39.5%
13
  35.1%
41
  40.2%
Male
14
  51.9%
23
  60.5%
24
  64.9%
61
  59.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 38 participants 37 participants 102 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.7%
1
   1.0%
Asian
0
   0.0%
1
   2.6%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
27
 100.0%
37
  97.4%
36
  97.3%
100
  98.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 38 participants 37 participants 102 participants
United States 16 25 22 63
Canada 2 6 3 11
Australia 2 2 2 6
New Zealand 0 1 1 2
United Kingdom 0 1 3 4
Poland 7 3 6 16
Primary Clinical Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 38 participants 37 participants 102 participants
Parkinson's Disease 10 20 18 48
Multiple System Atrophy 10 8 9 27
Pure Autonomic Failure 3 8 7 18
Dopamine Beta-Hydroxylase Deficiency 0 1 0 1
Non-Diabetic Autonomic Neuropathy 3 0 2 5
Other 1 1 1 3
1.Primary Outcome
Title Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)
Hide Description

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.

Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.57  (1.891) 0.90  (1.550)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.
2.Secondary Outcome
Title Change in Orthostatic Hypotension Daily Activities (OHDAS) Score
Hide Description

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).

Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One droxidopa patient excluded from analysis because data were not evaluable.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.53  (2.204) 0.71  (1.629)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.554
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.
3.Secondary Outcome
Title Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score
Hide Description

The 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).

Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.59  (1.963) 1.10  (1.658)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.
4.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing
Hide Description Change: 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.
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Mean (Standard Deviation)
Unit of Measure: mmHg
-8.4  (26.63) 0.0  (18.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.
5.Secondary Outcome
Title Patient Reported Clinical Global Impression - Severity
Hide Description

The 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). .
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: participants
Normal-Borderline OH 13 12
Mild-Moderate OH 16 13
Marked OH-Most ill with OH 9 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Clinician Recorded Clinical Global Impression - Severity
Hide Description

The 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).
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: participants
Normal-Borderline OH 9 7
Mild-Moderate OH 16 15
Marked OH-Most ill with OH 13 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.873
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Patient Reported Clinical Global Impression - Improvement
Hide Description

The 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).
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: participants
Very much - Slightly Improved 25 20
No Change 7 5
Slightly - Very much Worse 6 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Clinician Rated Clinical Global Impressions - Improvement
Hide Description

The 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).
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: participants
Very much - Slightly Improved 26 20
No Change 4 8
Slightly - Very much Worse 8 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Post-Hoc Outcome
Title Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
Hide Description OHSA 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.
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 38 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (2.39) 1.3  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Droxidopa, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.251
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Three Month Open-Label Droxidopa Double-blind Droxidopa Double-blind Placebo Long-Term Follow-up Total Droxidopa
Hide Arm/Group Description all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)

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: 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 with droxidopa (t.i.d) following the double-blind randomization phase. All Patients exposed to droxidopa
All-Cause Mortality
Three Month Open-Label Droxidopa Double-blind Droxidopa Double-blind Placebo Long-Term Follow-up Total Droxidopa
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Three Month Open-Label Droxidopa Double-blind Droxidopa Double-blind Placebo Long-Term Follow-up Total Droxidopa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/102 (11.76%)      1/38 (2.63%)      0/37 (0.00%)      16/74 (21.62%)      26/102 (25.49%)    
Cardiac disorders           
Angina pectoris  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 2/102 (1.96%)  2
Atrial fibrillation  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Coronary artery disease  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Ear and labyrinth disorders           
Vertigo  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Gastrointestinal disorders           
Diverticulum  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
General disorders           
Sudden cardiac death  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Infections and infestations           
Urinary tract infection  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 2/74 (2.70%)  2 2/102 (1.96%)  2
Pneumonia  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 2/74 (2.70%)  2 2/102 (1.96%)  2
Injury, poisoning and procedural complications           
Contusion  0/102 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Facial bones fracture  0/102 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Fall  0/102 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Hip fracture  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 2/74 (2.70%)  2 3/102 (2.94%)  3
Cervical vertebral fracture  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Pelvic fracture  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Metabolism and nutrition disorders           
Dehydration  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Osteoarthritis  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Nervous system disorders           
Syncope  1/102 (0.98%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0 2/74 (2.70%)  2 4/102 (3.92%)  4
Headache  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Hypoxic encephalopathy  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Loss of consciousness  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Dementia  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Psychiatric disorders           
Agitation  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Anxiety  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Confusional state  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Depression  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Hallucination  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Hallucination, visual  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Major depression  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Post-traumatic stress disorder  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Renal and urinary disorders           
Renal failure acute  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Bronchial haemorrhage  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Respiratory distress  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Surgical and medical procedures           
Malignant tumour excision  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Vascular disorders           
Venous thrombosis limb  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/74 (0.00%)  0 1/102 (0.98%)  1
Deep vein thrombosis  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Orthostatic hypotension  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 1/102 (0.98%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Three Month Open-Label Droxidopa Double-blind Droxidopa Double-blind Placebo Long-Term Follow-up Total Droxidopa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/102 (36.27%)      8/38 (21.05%)      4/37 (10.81%)      43/74 (58.11%)      62/102 (60.78%)    
General disorders           
Edema peripheral  0/102 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 4/74 (5.41%)  5 4/102 (3.92%)  5
Infections and infestations           
Urinary Tract Infection  9/102 (8.82%)  10 2/38 (5.26%)  2 0/37 (0.00%)  0 11/74 (14.86%)  18 17/102 (16.67%)  31
Bacteriuria  2/102 (1.96%)  2 0/38 (0.00%)  0 0/37 (0.00%)  0 4/74 (5.41%)  4 5/102 (4.90%)  6
Upper respiratory tract infection  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 4/74 (5.41%)  4 5/102 (4.90%)  5
Injury, poisoning and procedural complications           
Fall  7/102 (6.86%)  8 0/38 (0.00%)  0 1/37 (2.70%)  1 16/74 (21.62%)  20 20/102 (19.61%)  29
Musculoskeletal and connective tissue disorders           
Back pain  4/102 (3.92%)  4 2/38 (5.26%)  2 0/37 (0.00%)  0 7/74 (9.46%)  8 11/102 (10.78%)  14
Muscle Spasms  2/102 (1.96%)  2 1/38 (2.63%)  1 0/37 (0.00%)  0 4/74 (5.41%)  4 7/102 (6.86%)  7
Neck Pain  3/102 (2.94%)  3 0/38 (0.00%)  0 0/37 (0.00%)  0 3/74 (4.05%)  3 6/102 (5.88%)  6
Nervous system disorders           
Headache  5/102 (4.90%)  6 1/38 (2.63%)  1 2/37 (5.41%)  2 6/74 (8.11%)  6 13/102 (12.75%)  15
Syncope  4/102 (3.92%)  5 1/38 (2.63%)  2 0/37 (0.00%)  0 7/74 (9.46%)  9 10/102 (9.80%)  17
Dizziness  2/102 (1.96%)  2 1/38 (2.63%)  1 1/37 (2.70%)  1 5/74 (6.76%)  8 8/102 (7.84%)  12
Tremor  2/102 (1.96%)  2 0/38 (0.00%)  0 0/37 (0.00%)  0 4/74 (5.41%)  5 5/102 (4.90%)  7
Somnolence  5/102 (4.90%)  5 0/38 (0.00%)  0 0/37 (0.00%)  0 1/74 (1.35%)  1 6/102 (5.88%)  6
Psychiatric disorders           
Insomnia  1/102 (0.98%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 4/74 (5.41%)  4 5/102 (4.90%)  5
Vascular disorders           
Orthostatic hypotension  3/102 (2.94%)  4 0/38 (0.00%)  0 0/37 (0.00%)  0 3/74 (4.05%)  3 6/102 (5.88%)  7
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Scientific Officer
Organization: Chelsea Therapeutics Inc.
Phone: 704-973-4202
Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT00738062     History of Changes
Other Study ID Numbers: Droxidopa NOH303
First Submitted: August 19, 2008
First Posted: August 20, 2008
Results First Submitted: March 18, 2014
Results First Posted: May 16, 2014
Last Update Posted: May 16, 2014