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| Sponsored by: |
Hemispherx Biopharma |
|---|---|
| Information provided by: | Hemispherx Biopharma |
| ClinicalTrials.gov Identifier: | NCT00215800 |
Purpose
multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Fatigue Syndrome Myalgic Encephalomyelitis |
Drug: Ampligen |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy 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) |
| Estimated Enrollment: | 234 |
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
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
-
Contacts and Locations
More Information
| Study ID Numbers: | AMP 516 |
| Study First Received: | September 16, 2005 |
| Last Updated: | September 16, 2005 |
| ClinicalTrials.gov Identifier: | NCT00215800 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Fatigue Syndrome Myalgic Encephalomyelitis Chronic Fatigue Syndrome |
CFS Ampligen Poly I:ploy C12U |
|
Fatigue Central Nervous System Diseases Encephalomyelitis Fatigue Syndrome, Chronic Brain Diseases Antiviral Agents Encephalitis Ampligen |
Virus Diseases Signs and Symptoms Muscular Diseases Central Nervous System Infections Musculoskeletal Diseases Neuromuscular Diseases Myalgic Encephalomyelitis |
|
Anti-Infective Agents Disease Fatigue Nervous System Diseases Central Nervous System Diseases Encephalomyelitis Fatigue Syndrome, Chronic Brain Diseases Antiviral Agents Pharmacologic Actions Encephalitis |
Ampligen Virus Diseases Signs and Symptoms Pathologic Processes Muscular Diseases Neuromuscular Diseases Central Nervous System Infections Musculoskeletal Diseases Therapeutic Uses Syndrome |