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

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ClinicalTrials.gov Identifier: NCT00977171
Recruitment Status : Terminated (Enrollment issues.)
First Posted : September 15, 2009
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
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 Chronic Fatigue Syndrome
Orthostatic Hypotension
Neurally Mediated Hypotension
Neurogenic Orthostatic Hypotension
Intervention Drug: Droxidopa
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Droxidopa
Hide Arm/Group Description 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
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Droxidopa
Hide Arm/Group Description 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
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
3 patients enrolled in the study before it was stopped for difficulty recruiting subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
51.8  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Patient Global Impression of 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.
Time Frame Baseline to end of 12 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
3 patients enrolled in the study prior to it being stopped due to difficulty enrolling patients.
Arm/Group Title Droxidopa
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
3  (2.64)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Droxidopa
Hide Arm/Group Description 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
All-Cause Mortality
Droxidopa
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Droxidopa
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Droxidopa
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Gastrointestinal disorders   
Nausea  2/3 (66.67%)  6
Diarrhoea  1/3 (33.33%)  1
Abdominal pain upper  1/3 (33.33%)  1
Infections and infestations   
Localised infection  1/3 (33.33%)  1
Investigations   
Heart rate increased  1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Fibromyalgia  1/3 (33.33%)  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
Name/Title: Chief Scientific Officer
Organization: Chelsea Therapeutics Inc.
Phone: 704-973-4202
Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT00977171     History of Changes
Other Study ID Numbers: Droxidopa CFS201
First Submitted: September 11, 2009
First Posted: September 15, 2009
Results First Submitted: April 24, 2014
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014