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

Further study details as provided by Hemispherx Biopharma:

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00215813

Sharon Conway      215-988-0080    sharon@hemispherx.net

Study chairs or principal investigators

Daniel Peterson, M.D.,  Principal Investigator,  Sierra Internal Medicine   
Lucinda Bateman, M.D.,  Principal Investigator,  Fatigue Consultation Clinic   
Charles W. Lapp, M.D.,  Principal Investigator,  Hunter-Hopkins Center, P.A.   

Study ID Numbers:  AMP 511
Last Updated:  October 24, 2006
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00215813
Health Authority: United States: Food and Drug Administration

 

 

ClinicalTrials.gov: Fatigue Syndrome, Chronic  (National Institutes of Health)

Chronic Fatigue Syndrome  (American Academy of Family Physicians)

Chronic Fatigue Syndrome  (Mayo Foundation for Medical Education and Research)

Teens with Chronic Fatigue Syndrome Benefit from Behavior Therapy  (Nemours Foundation)

Chronic Fatigue Syndrome: Information Resources  (National Institute of Allergy and Infectious Diseases)

Chronic Fatigue Syndrome  (National Center for Infectious Diseases)

Chronic Fatigue Syndrome: Support Groups  (Centers for Disease Control and Prevention)

Possible Causes of Chronic Fatigue Syndrome  (Centers for Disease Control and Prevention)

Chronic Fatigue Syndrome: Treatment Options  (Centers for Disease Control and Prevention)

What's in a Name: Fibromyalgia Versus Chronic Fatigue Syndrome (CFS)  (Arthritis Foundation)

Chronic Fatigue Syndrome: Glossary  (Centers for Disease Control and Prevention)

Diet, Exercise, Stress and the Immune System: What You Can Do to Help  (Cleveland Clinic Foundation)

How CFS and Fibromyalgia Stress Can Make You Gain Weight  (National Fibromyalgia Association)