drugset / Trial / NCT00977171

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

NCT00977171

Phase 2 Terminated 3 enrolled Chelsea Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-07
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Droxidopa Small molecule 100 mg Oral
Subject Droxidopa Small molecule 200 mg Oral
Subject Droxidopa Small molecule 300 mg Oral
Subject Droxidopa Small molecule 400 mg Oral
Subject Droxidopa Small molecule 500 mg Oral
Subject Droxidopa Small molecule 600 mg Oral