NCT00215800

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (planned)
• Sponsor: AIM ImmunoTech Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Chronic Fatigue Syndrome
• Myalgic Encephalomyelitis

Interventions

Type	Name	Description
DRUG	Ampligen

Timeline

• Start date: 1998-12-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2005-09-22
• Last updated: 2013-04-17