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

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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)

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
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Chronic Fatigue Syndrome

Intervention

Ampligen


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

234

Start Date

December 1998

Completion Date

February 2004

Primary Completion Date

February 2004

Eligibility Criteria

        Inclusion Criteria:

          1. A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case
             definition) > 12 months (Appendix D).

          2. Age Range: > 18 years old, < 60 years old.

          3. 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.

          4. 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).

          5. 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.

          6. 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).

          7. 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.

          8. Ability to provide written informed consent indicating awareness of the
             investigational nature of this study.

        Exclusion Criteria:

        -
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

David R Strayer, MD, , 



Administrative Informations


NCT ID

NCT00215800

Organization ID

AMP 516


Responsible Party

Sponsor

Study Sponsor

AIM ImmunoTech Inc.


Study Sponsor

David R Strayer, MD, Study Director, AIM ImmunoTech Inc.


Verification Date

April 2013