Study of Ampligen in Chronic Fatigue Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hemispherx Biopharma
Sponsor:
Information provided by (Responsible Party):
Hemispherx Biopharma
ClinicalTrials.gov Identifier:
NCT00215813
First received: September 16, 2005
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Chronic Fatigue Syndrome
Drug: Poly I: Poly C12U
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN®)IN Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)

Resource links provided by NLM:


Further study details as provided by Hemispherx Biopharma:

Primary Outcome Measures:
  • Safety [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
    Evaluate safety


Secondary Outcome Measures:
  • Quality of Life Assessments [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
    Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), SF-36 and SCL-90


Estimated Enrollment: 100
Study Start Date: March 1997
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Poly I: Poly C12U
200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
Drug: Poly I: Poly C12U
200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
Other Names:
  • Ampligen
  • Rintatolimod

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 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Chronic Fatigue Syndrome (> 12 months) as defined by the 1988 Centers for Disease Control and Prevention CDC case definition for CFS or as defined only by the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959) (other clinical conditions which could present with similar symptoms must be excluded.).
  2. Age Range: >= 18 years old, <= 70 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.

Exclusion Criteria:

  1. Inability to return for scheduled treatment and assessments.
  2. Chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe.
  3. Pregnant or lactating females.
  4. Therapy with immunomodulatory drugs (including gamma globulin, systemic steroids, interferons), antivirals (including acyclovir, AZT and/or other antiviral nucleoside analogues) or investigational drugs within the past 6 weeks. Subjects must give written informed consent prior to discontinuation of any medications.
  5. Necessity to continue aspirin or other nonsteroidal anti-inflammatory drugs for thirty (30) consecutive days or for more than 20% of study duration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215813

Contacts
Contact: Diane Young 732-249-3250 ext 609 diane.young@hemispherx.net
Contact: Ann Marie Coverly 215-988-0080 ext 115 annmarie.coverly@hemispherx.net

Locations
United States, Florida
Nova Southeastern University Chronic Fatigue Center Recruiting
Miami, Florida, United States, 33176
Contact: Ernesto Martinez Duarte    305-595-4300    emartinezduarte@nova.edu   
Principal Investigator: Nancy Klimas, MD         
United States, Nevada
Dr. Daniel Peterson Recruiting
Incline Village, Nevada, United States, 89451
Contact: Kathleen Colley    775-832-0989    kcolley@sierrainternalmed.com   
Principal Investigator: Daniel Peterson, MD         
United States, New York
Dr. Derek Enlander Recruiting
New York, New York, United States, 10065
Contact: Laura Melilli    212-794-2000    mecfsoffice@enlander.com   
Principal Investigator: Derek Enlander, MD         
United States, North Carolina
Hunter-Hopkins Center, PA Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Wendy Springs    704-543-9692    wendy@drlapp.net   
Principal Investigator: Charles Lapp, MD         
United States, Utah
The Fatigue Consultation Clinic Recruiting
Salt Lake City, Utah, United States, 84102
Contact: Ali Allen       ali@fcclinic.com   
Principal Investigator: Lucinda Bateman, MD         
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.
Principal Investigator: Nancy Klimas, M.D. Nova Southeastern University Chronic Fatigue Center
Principal Investigator: Derek Enlander, MD Private Practice CFIDS Fibromyalgia & CFS
  More Information

Additional Information:
No publications provided

Responsible Party: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00215813     History of Changes
Other Study ID Numbers: AMP 511
Study First Received: September 16, 2005
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Poly I-C
Poly(I).poly(c12,U)
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014