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March 15, 2006
This study is currently recruiting patients.
Verified by Hemispherx Biopharma September 2005
Sponsored by: Hemispherx Biopharma
Information provided by: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00215813
Purpose:
An Open Label Study of Ampligen in Chronic Fatigue Syndrome
Condition:Chronic Fatigue Syndrome/ME
Intervention Drug: Ampligen (poly I: poly C12U)
Phase III
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study
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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years;
Genders Eligible for Study: Both
Inclusion Criteria:
1. Diagnosis of Myalgic Encephalomyelitis (ME) as defined by the 1988 CDC case definition for Chronic Fatigue Syndrome (CFS) ongoing for ³ 12 months (other clinical conditions which could present with similar symptoms must be excluded).
2. Age Range: ³ 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 ³ 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 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.
Exclusion Criteria:
Location and Contact Information
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.
More Information
Study ID Numbers: AMP 511
Last Updated: December 8, 2005
Record first received: September 16, 2005
ClinicalTrials.gov Identifier: NCT00215813
Health Authority: United States: Food and Drug Administration
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