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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hemispherx Biopharma
ClinicalTrials.gov Identifier:
NCT00215800
First received: September 16, 2005
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Drug: Ampligen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Hemispherx Biopharma:

Estimated Enrollment: 234
Study Start Date: December 1998
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215800

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

No publications provided by Hemispherx Biopharma

Additional 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
Study First Received: September 16, 2005
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Encephalomyelitis
Fatigue
Fatigue Syndrome, Chronic
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Ampligen
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014