An Open-Label Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome

This is a phase II, single-center, open-label study to evaluate the efficacy and safety of droxidopa in subjects with chronic fatigue syndrome. The study will enroll enough subjects to allow 10 to be placed in the 12 week open label treatment period.

The study will consist of an initial screening period (up to 7 days) to confirm eligibility followed by an up to 2 week dose titration period, a 12 week treatment period and a 30 day follow up period to account for any new or on-going AEs. During the screening visit the following assessments will be recorded:

• Demography;
• Medical history;
• Physical examination;
• ECG;
• Vital signs (BP, HR, weight)
• Stand Test (measurement of BP and heart rate in the supine position (head and torso elevated at approximately 30° from horizontal) 10, 5, immediately before and 1, 5 and 10 minutes after standing);
• Tilt Table Test
• Blood samples for hematology and biochemistry;
• Urine sample for urinalysis
• Pregnancy test for females of child bearing potential.
• Concomitant medication review o Subjects taking ephedrine or midodrine will stop taking these drugs for at least 7 days before the baseline assessments.

Within 7 days of successful screening, the following baseline assessments will be recorded:

• Inclusion/Exclusion review;
• Standing test (measurement of BP and heart rate 10, 5, immediately before and 1, 5 and 10 minutes after standing);
• Vital signs (BP, HR, and weight);
• Urine/serum pregnancy test for WOCP;
• Concomitant medications;
• Adverse events
• Multidimensional Fatigue Inventory (MFI);
• Brief Pain Inventory (BPI);
• Clinical Global Impression of Severity (CGI-S);
• Hospital Anxiety and Depression Scale (HADS);
• Patient Global Impression of Improvement (PGI-I).