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| Sponsor: | 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:
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 |
|
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 |