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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
Information provided by (Responsible Party):
Hemispherx Biopharma

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

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Myalgic Encephalomyelitis Drug: Ampligen Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D).
  2. Age Range: > 18 years old, < 60 years old.
  3. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two (2) years or surgically sterile including tubal ligation) or using an effective means of contraception (birth control pills, intrauterine device, diaphragm). Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test within the two (2) weeks prior to the first study medication infusion. Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion.
  4. A reduced quality of life as determined by a documented KPS of 40 to 60 on three (3) occasions, each at least 14 days apart, during the twelve (12) weeks immediately preceding the start of study drug infusions. The KPS must be rounded in increments of ten (10).
  5. Ability to walk (minimum of 20 seconds) on the moving treadmill (grade = 0%; belt speed = 1 mph) on a minimum of two (2) occasions during the twelve (12) weeks immediately preceding study entry.
  6. Laboratory documentation (baseline or historical following onset of CFS/ME) of a negative ANA or a negative anti-ds (double-stranded) DNA, a negative Rheumatoid Factor, and an erythrocyte sedimentation rate (ESR).
  7. Laboratory documentation that the patient is euthyroid (patients on thyroid replacement therapy must be on a stable dose during the eight (8) week washout period) based on a thyroid profile (T4, T3, TSH, T3 uptake and Free T4 index) performed during baseline.
  8. Ability to provide written informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

Information from the National Library of Medicine

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

Sponsors and Collaborators
Hemispherx Biopharma
Study Director: David R Strayer, MD Hemispherx Biopharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00215800     History of Changes
Other Study ID Numbers: AMP 516
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Hemispherx Biopharma:
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Poly I:ploy C12U

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Pain
Neurologic Manifestations
Poly I-C
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs