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

• ClinicalTrials.gov Identifier: NCT00215800
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: April 17, 2013
• Sponsor: AIM ImmunoTech Inc.
• Information provided by (Responsible Party): AIM ImmunoTech Inc.

Study Description

Brief Summary:

multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.

Condition or disease	Intervention/treatment	Phase
Chronic Fatigue Syndrome; Myalgic Encephalomyelitis	Drug: Ampligen	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: December 1998
• Actual Primary Completion Date: February 2004
• Actual Study Completion Date: February 2004

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

-

Contacts and Locations

Sponsors and Collaborators

AIM ImmunoTech Inc.

Investigators

• Study Director: David R Strayer, MD; AIM ImmunoTech Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: AIM ImmunoTech Inc.
• ClinicalTrials.gov Identifier: NCT00215800
• Other Study ID Numbers: AMP 516
• First Posted: September 22, 2005
• Last Update Posted: April 17, 2013
• Last Verified: April 2013

Keywords provided by AIM ImmunoTech Inc.:

Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; CFS; Ampligen; Poly I:ploy C12U

Additional relevant MeSH terms:

Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Syndrome; Fatigue; Disease; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; poly(I).poly(c12,U); Antiviral Agents; Anti-Infective Agents