Clinical Trial: The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Poly I:Poly C12U (Ampligen®) 400 mg IV Twice Weekly Versus Placebo in Patients With Severely Debil

Brief Summary: multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.

Detailed Summary:

This study will be a prospective, double-blind, randomized, placebo-controlled, equal parallel groups study conducted at up to fifteen (15) centers to compare the safety and efficacy of Ampligen® IV versus placebo IV in 230-240 patients with CFS/ME. Patients will be randomized and stratified to receive either Ampligen® intravenously or placebo (normal saline) intravenously. Fifty percent (50%) of the patients will be treated with Ampligen® IV and 50% of the patients will be treated with placebo IV.

Patients will be studied until 64 weeks (STAGES I plus II) have passed or until: 1) removed because of toxicity, 2) they withdraw voluntarily, 3) a change in the patient's medical condition makes continued participation unsafe, 4) the patient becomes non-compliant with the requirements of the protocol or 4) the Sponsor terminates the study.

Official Title: A multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy of poly I:poly C12U (Ampligen®) 400 mg IV twice weekly versus placebo in patients with severely debilitating chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME)

Further Study Details

Enrollment = 234: Study Completed

Sponsor: Hemispherx Biopharma

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hemispherx Biopharma

Dates:
Date Received: September 16, 2005
Date Started: December 1998
Date Completion:
Last Updated: April 16, 2013
Last Verified: April 2013