Ampligen in Chronic Fatigue Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hemispherx Biopharma
ClinicalTrials.gov Identifier:
NCT00215813
First received: September 16, 2005
Last updated: April 19, 2016
Last verified: April 2016
  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 (Rintatolimod)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety 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 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
CFS patients will receive 200-400 mg IV infusions of Poly I: Poly C12U (Rintatolimod) given twice weekly over a period of 30-60 minutes
Drug: Poly I: Poly C12U (Rintatolimod)
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Group 1 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). Alternatively, female patients with a male partner having a successful vasectomy (considered successful if a volunteer reports that a male partner has either documentation of azoospermia by microscopy or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy).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 at baseline within the four (4) weeks prior to the first study medication infusion. Every four weeks, and at study termination a pregnancy test should be performed, either serum or urine stick test. However, if the urine result is positive, a serum pregnancy test will be performed. 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. All male patients agree not to be a sperm donor and to use an effective means of contraception while on study medication and until 90 days 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 the onset of CFS) 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.

Group 1 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 interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. Subjects must give written informed consent prior to discontinuation of investigational drugs.

Group 2 Inclusion Criteria:

1. Same as Group 1 Inclusion Criteria numbers 2, 3 and 5 listed above.

Group 2 Exclusion Criteria:

1. Same as all Group 1 Exclusion Criteria listed above.

Group 3 Inclusion Criteria:

1. Same as Group 1 Inclusion Criteria numbers 1, 2, 3, 4 and 5 listed above.

Group 3 Exclusion Criteria:

1. Same as all Group 1 Exclusion Criteria listed above.

  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

Locations
United States, Florida
Nova Southeastern University Chronic Fatigue Center
Miami, Florida, United States, 33176
United States, Nevada
Dr. Daniel Peterson
Incline Village, Nevada, United States, 89451
United States, New York
Dr. Derek Enlander
New York, New York, United States, 10065
United States, North Carolina
Hunter-Hopkins Center, PA
Charlotte, North Carolina, United States, 28210
United States, Utah
Bateman Horne Center
Salt Lake City, Utah, United States, 84102
Sponsors and Collaborators
Hemispherx Biopharma
Investigators
Principal Investigator: Daniel Peterson, M.D. Sierra Internal Medicine
Principal Investigator: Lucinda Bateman, M.D. Bateman Horne Center
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:
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 19, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on July 26, 2016