Clinical Trial: Ampligen in Chronic Fatigue Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN®) in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)
Brief Summary: This is an open label study of Ampligen in patients with chronic fatigue syndrome.
Detailed Summary: An Open-Label Study of Poly I: Poly C12U (Ampligen®) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing.
Sponsor: Hemispherx Biopharma
Current Primary Outcome: Safety [ Time Frame: Every 4 weeks ]
Original Primary Outcome:
Current Secondary Outcome: Quality of Life Assessments [ Time Frame: Every 12 weeks ]
Original Secondary Outcome:
Information By: Hemispherx Biopharma
Dates:
Date Received: September 16, 2005
Date Started: March 1997
Date Completion: February 2018
Last Updated: August 3, 2016
Last Verified: August 2016