Multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.
The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome
Medical trial
ClinicalTrials.gov Identifier:
- NCT00215800
Sponsor:
Type of trial:
Design:
View entire collection »Phase:
Expected total enrollment:
- 234
Minimum age for eligibility:
- 18
Maximum age for eligibility:
- 60
Eligibility inclusion criteria:
- 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
- Ability to provide written informed consent indicating awareness of the investigational nature of this study
- Males or non-pregnant, non-lactating females
- 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)
- 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
- 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)
- A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D)A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D)
Health authority:
Diseases:
Treatment being tested:
Related Topics
-
Oral Collagen for Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of... -
Alendronate and/or Parathyroid Hormone for Osteoporosis
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone... -
Nimotuzumab in Adults With Glioblastoma Multiforma
From http://clinicaltrials.gov "The objective of the present study is a comparison of treatment... -
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar...
