Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) (NOH304)

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. Identifier: NCT01132326
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : April 21, 2014
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Chelsea Therapeutics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Primary Autonomic Failure
Dopamine Beta Hydroxylase Deficiency
Non-Diabetic Neuropathy
Neurogenic Orthostatic Hypotension
Intervention: Drug: Droxidopa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Open-Label Droxidopa

Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

Participant Flow:   Overall Study
STARTED   350 
Lack of Efficacy                25 
Adverse Event                37 
Protocol Violation                1 
Lost to Follow-up                16 
Withdrawal by Subject                40 
Physician Decision                10 
Study Termination                80 
Declining Health                1 
Pregnancy                1 
Caregiver Withdrew Consent                1 
Death                5 
Subject Unable to Come To Visits                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

Open-Label Droxidopa

Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 65.9  (15.16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      136  38.9% 
Male      214  61.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      2   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4   1.1% 
White      344  98.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   263 
Europe   87 
Primary Clinical Diagnosis 
[Units: Participants]
Parkinson's Disease   232 
Multiple System Atrophy   33 
Pure Autonomic Failure   68 
Dopamine Beta-Hydroxylase Deficiency   0 
Non-Diabetic Autonomic Neuropathy   8 
Other   7 
Missing   2 

  Outcome Measures

1.  Primary:   Patients With Treatment-emergent Adverse Events   [ Time Frame: up to 2 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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 Identifier: NCT01132326     History of Changes
Other Study ID Numbers: Droxidopa NOH304
First Submitted: September 9, 2009
First Posted: May 28, 2010
Results First Submitted: March 18, 2014
Results First Posted: April 21, 2014
Last Update Posted: March 15, 2017