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 ]

Evaluate safety


Original Primary Outcome:

Current Secondary Outcome: Quality of Life Assessments [ Time Frame: Every 12 weeks ]

Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), SF-36 and SCL-90


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