Fibromyalgia Clinical Trial
Official title:
Neurotropin Treatment of Fibromyalgia
This study will examine the safety and effectiveness of the experimental drug, neurotropin,
for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects
women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been
used in Japan for many years to treat various chronic painful conditions, including
fibromyalgia.
Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be
eligible for this study. Patients must have a history of widespread pain for more than half
of the days in each of the three months before they enter the study. Candidates are screened
with a medical history, physical examination, blood and urine tests, questionnaires and an
electrocardiogram (EKG).
Participants take their usual medications for fibromyalgia in addition to either neurotropin
or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into
the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain
and level of physical capability. After 12 weeks, study subjects "cross-over" their
medication; that is, patients who took neurotropin for the first 12 weeks of the study take
placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return
for evaluation.
Participants have blood and urine tests six times during the study and complete
questionnaires each week about their pain, symptoms, and activities.
Fibromyalgia is a relatively common disorder, which occurs predominantly in women, that is characterized by widespread aching and stiffness in muscles. Although there have been numerous studies of fibromyalgia, its etiology has remained unclear, but it is generally believed that central pain processing abnormalities are involved. Neurotropin, a non-protein extract of inflamed cutaneous tissue from rabbits inoculated with vaccinia virus, has been used extensively in Japan for many years to treat a variety of chronic painful conditions, including fibromyalgia. This present protocol is a double blind, placebo-controlled, crossover study designed to examine the clinical efficacy of Neurotropin in treating women (neither pregnant nor lactating) suffering from fibromyalgia without evidence of any other cause of their complaint of pain. Patients must meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia and must agree to maintain a stable therapeutic regimen throughout the 25-week study. ;
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