Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome (CFS201)
A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not precisely understood, a dysfunction of the autonomic nervous system is thought to play a role in this subset of patients. In several small studies, subjects within this subset have noted improvement in their chronic fatigue symptoms when treated for their neurally mediated hypotension. As droxidopa acts on the autonomic nervous system and has been shown to ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could aid in the treatment of chronic fatigue symptoms.
Neurally mediated hypotension has been associated with patients suffering from chronic fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be clinically beneficial.
|Chronic Fatigue Syndrome Orthostatic Hypotension Neurally Mediated Hypotension Neurogenic Orthostatic Hypotension||Drug: Droxidopa||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-Label Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome|
- Patient Global Impression of Improvement [ Time Frame: Baseline to end of 12 week treatment period ]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.
|Study Start Date:||July 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977171
|United States, North Carolina|
|7421 Carmel Executive Park Drive, Ste. 320|
|Charlotte, North Carolina, United States, 28226|
|Principal Investigator:||Charles W Lapp, M.D.||Hunter-Hopkins Center, P.A.|