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The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ampligen
Sponsored by
AIM ImmunoTech Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, CFS, Ampligen, Poly I:ploy C12U

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D). Age Range: > 18 years old, < 60 years old. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two (2) 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 two (2) 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. A reduced quality of life as determined by a documented KPS of 40 to 60 on three (3) occasions, each at least 14 days apart, during the twelve (12) weeks immediately preceding the start of study drug infusions. The KPS must be rounded in increments of ten (10). Ability to walk (minimum of 20 seconds) on the moving treadmill (grade = 0%; belt speed = 1 mph) on a minimum of two (2) occasions during the twelve (12) weeks immediately preceding study entry. Laboratory documentation (baseline or historical 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). Laboratory documentation that the patient is euthyroid (patients on thyroid replacement therapy must be on a stable dose during the eight (8) week washout period) based on a thyroid profile (T4, T3, TSH, T3 uptake and Free T4 index) performed during baseline. Ability to provide written informed consent indicating awareness of the investigational nature of this study. Exclusion Criteria: -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2005
    Last Updated
    April 16, 2013
    Sponsor
    AIM ImmunoTech Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00215800
    Brief Title
    The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome
    Official Title
    A Multi-center, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Poly I:Poly C12U (Ampligen®) 400 mg IV Twice Weekly Versus Placebo in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1998 (undefined)
    Primary Completion Date
    February 2004 (Actual)
    Study Completion Date
    February 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AIM ImmunoTech Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.
    Detailed Description
    This study will be a prospective, double-blind, randomized, placebo-controlled, equal parallel groups study conducted at up to fifteen (15) centers to compare the safety and efficacy of Ampligen® IV versus placebo IV in 230-240 patients with CFS/ME. Patients will be randomized and stratified to receive either Ampligen® intravenously or placebo (normal saline) intravenously. Fifty percent (50%) of the patients will be treated with Ampligen® IV and 50% of the patients will be treated with placebo IV. Patients will be studied until 64 weeks (STAGES I plus II) have passed or until: 1) removed because of toxicity, 2) they withdraw voluntarily, 3) a change in the patient's medical condition makes continued participation unsafe, 4) the patient becomes non-compliant with the requirements of the protocol or 4) the Sponsor terminates the study. Official Title: A multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy of poly I:poly C12U (Ampligen®) 400 mg IV twice weekly versus placebo in patients with severely debilitating chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) Further Study Details Enrollment = 234: Study Completed

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
    Keywords
    Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, CFS, Ampligen, Poly I:ploy C12U

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    234 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ampligen

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D). Age Range: > 18 years old, < 60 years old. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two (2) 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 two (2) 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. A reduced quality of life as determined by a documented KPS of 40 to 60 on three (3) occasions, each at least 14 days apart, during the twelve (12) weeks immediately preceding the start of study drug infusions. The KPS must be rounded in increments of ten (10). Ability to walk (minimum of 20 seconds) on the moving treadmill (grade = 0%; belt speed = 1 mph) on a minimum of two (2) occasions during the twelve (12) weeks immediately preceding study entry. Laboratory documentation (baseline or historical 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). Laboratory documentation that the patient is euthyroid (patients on thyroid replacement therapy must be on a stable dose during the eight (8) week washout period) based on a thyroid profile (T4, T3, TSH, T3 uptake and Free T4 index) performed during baseline. Ability to provide written informed consent indicating awareness of the investigational nature of this study. Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David R Strayer, MD
    Organizational Affiliation
    AIM ImmunoTech Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33119613
    Citation
    Strayer DR, Young D, Mitchell WM. Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. PLoS One. 2020 Oct 29;15(10):e0240403. doi: 10.1371/journal.pone.0240403. eCollection 2020.
    Results Reference
    derived
    PubMed Identifier
    22431963
    Citation
    Strayer DR, Carter WA, Stouch BC, Stevens SR, Bateman L, Cimoch PJ, Lapp CW, Peterson DL; Chronic Fatigue Syndrome AMP-516 Study Group; Mitchell WM. A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome. PLoS One. 2012;7(3):e31334. doi: 10.1371/journal.pone.0031334. Epub 2012 Mar 14.
    Results Reference
    derived

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    The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome

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