Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome (CFS201)

This study has been terminated.
(Enrollment issues.)
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics
ClinicalTrials.gov Identifier:
NCT00977171
First received: September 11, 2009
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: April 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Fatigue Syndrome
Orthostatic Hypotension
Neurally Mediated Hypotension
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
No text entered.

Reporting Groups
  Description
Droxidopa Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period

Participant Flow:   Overall Study
    Droxidopa  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  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.
3 patients enrolled in the study before it was stopped for difficulty recruiting subjects

Reporting Groups
  Description
Droxidopa Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period

Baseline Measures
    Droxidopa  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 11.0  
Gender  
[units: participants]
 
Female     3  
Male     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     3  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Patient Global Impression of Improvement   [ Time Frame: Baseline to end of 12 week treatment period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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: NCT00977171     History of Changes
Other Study ID Numbers: Droxidopa CFS201
Study First Received: September 11, 2009
Results First Received: April 24, 2014
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration