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A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa (NOH301)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00782340
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Chelsea Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Symptomatic Neurogenic Orthostatic Hypotension (NOH)
Non-diabetic Neuropathy
Primary Autonomic Failure
Dopamine Beta Hydroxylase Deficiency
Interventions Drug: Placebo
Drug: Droxidopa
Enrollment 263
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Titration Droxidopa Placebo
Hide Arm/Group Description All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.

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

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

Period Title: Open Label Titration
Started 263 0 0
Completed 162 0 0
Not Completed 101 0 0
Reason Not Completed
Adverse Event             12             0             0
Treatment failure             50             0             0
Protocol Violation             5             0             0
Withdrawal by Subject             5             0             0
Enrollment capped             16             0             0
Did not meet responder criteria             2             0             0
Lost to Follow-up             5             0             0
Randomized in error             6             0             0
Period Title: Randomized Double Blind
Started 0 82 80
Completed 0 82 80
Not Completed 0 0 0
Arm/Group Title Not Randomized Droxidopa Placebo Total
Hide Arm/Group Description Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.

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

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 of all reporting groups
Overall Number of Baseline Participants 101 82 80 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 82 participants 80 participants 263 participants
64.6  (15.4) 57.4  (16.90) 55.7  (20.03) 59.6  (17.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 82 participants 80 participants 263 participants
Female
37
  36.6%
40
  48.8%
38
  47.5%
115
  43.7%
Male
64
  63.4%
42
  51.2%
42
  52.5%
148
  56.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 82 participants 80 participants 263 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   2.0%
0
   0.0%
1
   1.3%
3
   1.1%
White
99
  98.0%
82
 100.0%
78
  97.5%
259
  98.5%
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 101 participants 82 participants 80 participants 263 participants
United States 48 33 32 113
Canada 3 0 4 7
Europe 50 49 44 143
Primary Clinical Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 82 participants 80 participants 263 participants
Parkinson's Disease 45 35 31 111
Multiple System Atrophy 18 15 11 44
Pure Autonomic Failure 33 26 28 87
Non-Diabetic Autonomic Neuropathy 2 2 6 10
Other Diagnosis 3 4 4 11
1.Primary Outcome
Title Change in Orthostatic Hypotension Questionnaire 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.

For the change from randomization, negative numbers represent improvement from randomization in OHQ score.

Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data are imputed using the last observation carried forward method.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.83  (2.067) -0.93  (1.691)
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 0.003
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.
Method ANCOVA
Comments ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.
2.Secondary Outcome
Title Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data are imputed using the last observation carried forward method.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.98  (2.310) -0.92  (1.816)
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 0.003
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.
Method ANCOVA
Comments ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.
3.Secondary Outcome
Title Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data are imputed using the last observation carried forward method.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.68  (2.125) -0.95  (1.901)
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 0.010
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.
Method ANCOVA
Comments ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.
4.Secondary Outcome
Title Change in Activities Involving Standing a Short Time (OHDAS Item 1)
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data are imputed using the last observation carried forward method.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.9  (2.75) -0.8  (2.60)
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 0.003
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.
5.Secondary Outcome
Title Change in Activities Involving Walking a Short Time (OHDAS Item 3)
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data are imputed using the last observation carried forward method.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.7  (2.55) -0.6  (2.37)
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 0.009
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.
Method ANCOVA
Comments ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.
6.Secondary 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. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data are imputed using the last observation carried forward method.
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (3.20) -1.1  (2.58)
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 <0.001
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.
Method Mantel Haenszel
Comments Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.
7.Secondary Outcome
Title Patient-Reported Clinical Global Improvement - Severity Scores
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 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 80
Measure Type: Number
Unit of Measure: participants
Normal-Borderline OH 23 16
Mild-Moderate OH 39 47
Marked OH-Most ill with OH 20 17
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 0.327
Comments Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Clinician-Reported Clinical Global Improvement - Severity Scores
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 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 80
Measure Type: Number
Unit of Measure: participants
Normal-Borderline OH 21 15
Mild-Moderate OH 39 44
Marked OH-Most ill with OH 22 21
9.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. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 82 79
Mean (Standard Deviation)
Unit of Measure: mmHg
11.2  (22.89) 3.9  (16.28)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Open-Label Titration Droxidopa Placebo
Hide Arm/Group Description All patients treated with study drug during dose titration (7-14 days)

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

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

All-Cause Mortality
Open-Label Titration Droxidopa Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label Titration Droxidopa Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/263 (0.76%)      0/81 (0.00%)      0/81 (0.00%)    
Gastrointestinal disorders       
Nausea  1/263 (0.38%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Vomiting  1/263 (0.38%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Infections and infestations       
Urinary Tract Infection  1/263 (0.38%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Renal and urinary disorders       
Neurogenic bladder  1/263 (0.38%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Ureteric obstruction  1/263 (0.38%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-Label Titration Droxidopa Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/263 (14.45%)      9/81 (11.11%)      1/81 (1.23%)    
Nervous system disorders       
Headache  26/263 (9.89%)  34 6/81 (7.41%)  7 0/81 (0.00%)  0
Dizziness  17/263 (6.46%)  18 3/81 (3.70%)  3 1/81 (1.23%)  1
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
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: Chelsea Therapeutics Inc.
Phone: 704-973-4202
EMail: hewitt@chelsearx.com
Layout table for additonal information
Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT00782340     History of Changes
Obsolete Identifiers: NCT00879567
Other Study ID Numbers: Droxidopa NOH301
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: March 18, 2014
Results First Posted: May 16, 2014
Last Update Posted: May 16, 2014