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Fibromyalgia Clinical Trial Accelerated
by Source: PRN Newswire
ImmuneSupport.com
04-28-1999
Fibromyalgia, a syndrome characterized by chronic pain in the soft tissues and estimated to affect about 7.5 million Americans, just got a little boost toward finding a cure. Amarillo Biosciences announced this week that it will expand its Phase II clinical trial of low dose oral interferon alpha (IFN alpha) to include three more sites. "A safe and effective therapy for this condition, with minimal side effects, would be of tremendous benefit to the millions of individuals who suffer with chronic symptoms of fibromyalgia. That is the reason we have added these additional clinical sites: to accelerate the completion of this exciting research," said Dr. Philip C. Fox, Director of Research and Development at Amarillo Biosciences, Inc. It is estimated that the cost of support payments for those with this condition is approximately $15 billion.
The new study sites are located in Oregon, Colorado and Illinois and will be added to the original site in Texas, where patients have been enrolled since July of 1998. The study will ultimately include 120 patients and will conclude at the end of this year.
All patients will be given low-dose amitriptyline (a tricyclic anti-depressant) at bedtime for four months. After the first month of this treatment, patients will be randomly assigned to placebo or low-dose oral IFN alpha. Each month during the study the subjects will be evaluated using visual analogue scale questionnaires that measure morning stiffness, physical function ability and pain. Additionally, the Stanford Health Assessment Questionnaire will be given at each visit. Measurements will include comprehensive data on morning stiffness at the beginning and end of the study, and quantitative assessment of pain severity and muscle tenderness.
Amarillo Biosciences is currently testing their low-dose IFN alpha (which has fewer and milder side effects and greater cost effectiveness than high-dose injectable interferon) on those with Sjogren's syndrome, and hepatitis B and C, in addition to those with fibromyalgia.
PRN Newswire, April 28, 1999
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