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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics
ClinicalTrials.gov Identifier:
NCT01132326
First received: September 9, 2009
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: March 18, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Primary Autonomic Failure
Dopamine Beta Hydroxylase Deficiency
Non-Diabetic Neuropathy
Neurogenic Orthostatic Hypotension
Intervention: Drug: Droxidopa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
Droxidopa

Open-Label Droxidopa

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


Participant Flow:   Overall Study
    Droxidopa  
STARTED     350  
COMPLETED     132  
NOT COMPLETED     218  
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
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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.
No text entered.

Reporting Groups
  Description
Droxidopa

Open-Label Droxidopa

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


Baseline Measures
    Droxidopa  
Number of Participants  
[units: participants]
  350  
Age  
[units: years]
Mean ± Standard Deviation
  65.9  ± 15.16  
Gender  
[units: participants]
 
Female     136  
Male     214  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     344  
More than one race     0  
Unknown or Not Reported     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


  More Information
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: Chelsea Therapeutics Inc.
phone: 704-973-4202
e-mail: hewitt@chelsearx.com


No publications provided


Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT01132326     History of Changes
Other Study ID Numbers: Droxidopa NOH304
Study First Received: September 9, 2009
Results First Received: March 18, 2014
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration