Chelsea Therapeutics has initiated an investigator-led Phase II study of Droxidopa as a treatment of chronic fatigue syndrome.
The trial will be an open-label study that will evaluate the clinical efficacy of 600mg of Droxidopa thrice daily. It will involve 20 patients who will be titrated to optimal therapeutic benefit over a period of two weeks, followed 12 weeks of treatment.
The primary outcome measure of the trial will be changes in Patient Global Impression of Improvement score from baseline at the end of this period.
Secondary outcome measures will include changes in Clinical Global Impression of Severity, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and blood pressure before and after a tilt table test.
The study will be conducted at the Hunter-Hopkins Center in Charlotte, North Carolina.
