The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome
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|ClinicalTrials.gov Identifier: NCT00215800|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome Myalgic Encephalomyelitis||Drug: Ampligen||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||December 1998|
|Primary Completion Date :||February 2004|
|Study Completion Date :||February 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215800
|Study Director:||David R Strayer, MD||Hemispherx Biopharma|