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Study of Ampligen in Chronic Fatigue Syndrome
This study is currently recruiting participants.
Verified by Hemispherx Biopharma, September 2005
First Received: September 16, 2005   Last Updated: October 24, 2006   History of Changes
Sponsored by: Hemispherx Biopharma
Information provided by: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00215813
  Purpose

This is an open label study of Ampligen in patients with chronic fatigue syndrome.


Condition Intervention Phase
Chronic Fatigue Syndrome
Drug: Ampligen (poly I: poly C12U)
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study
Official Title: An Open Label Study of Ampligen in Chronic Fatigue Syndrome

Resource links provided by NLM:


Further study details as provided by Hemispherx Biopharma:

Detailed Description:

An Open-Label Study of Poly I: Poly C12U (Ampligen®) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of myalgic encephalomyelitis (ME) as defined by the 1988 Centers for Disease Control and Prevention (CDC) case definition for chronic fatigue syndrome (CFS) ongoing for >= 12 months (other clinical conditions which could present with similar symptoms must be excluded).
  2. Age Range: >= 18 years old, <= 65 years old.
  3. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two 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 four (4) 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 Karnofsky performance score (KPS) of >= 20 and <= 60. The KPS must be rounded in increments of ten (10).
  5. Ability to provide written informed consent indicating awareness of the investigational nature of this study.
  6. Documentation (during baseline or historically following onset of CFS/ME) of a negative antinuclear antibody test (ANA) or a negative anti-ds (double-stranded) DNA, a negative rheumatoid factor, and an erythrocyte sedimentation rate (ESR). Documentation during baseline of a normal T4 (or other laboratory evidence that subject is euthyroid) is also required.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215813

Contacts
Contact: Sharon Conway 215-988-0080 sharon@hemispherx.net

  Show 51 Study Locations
Sponsors and Collaborators
Hemispherx Biopharma
Investigators
Principal Investigator: Daniel Peterson, M.D. Sierra Internal Medicine
Principal Investigator: Lucinda Bateman, M.D. Fatigue Consultation Clinic
Principal Investigator: Charles W. Lapp, M.D. Hunter-Hopkins Center, P.A.
  More Information

No publications provided

Study ID Numbers: AMP 511
Study First Received: September 16, 2005
Last Updated: October 24, 2006
ClinicalTrials.gov Identifier: NCT00215813     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Hemispherx Biopharma:
Chronic Fatigue Syndrome
CFS
ME
Ampligen
poly I:poly C12U

Study placed in the following topic categories:
Fatigue
Immunologic Factors
Interferons
Central Nervous System Diseases
Encephalomyelitis
Fatigue Syndrome, Chronic
Antiviral Agents
Ampligen
Virus Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Myalgic Encephalomyelitis
Poly I-C

Additional relevant MeSH terms:
Interferon Inducers
Anti-Infective Agents
Fatigue
Disease
Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Encephalomyelitis
Fatigue Syndrome, Chronic
Antiviral Agents
Pharmacologic Actions
Ampligen
Virus Diseases
Signs and Symptoms
Muscular Diseases
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Syndrome
Poly I-C

ClinicalTrials.gov processed this record on July 06, 2009