Neurotropin Treatment of Fibromyalgia

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:18 - Any
Start Date:August 2006
End Date:December 2015

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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

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.


Subjects will be drawn from a cohort of well-characterized female fibromyalgia patients who
were under the care of Dr. Daniel. J. Clauw when he was at Georgetown University. All
patients must continue to meet the criteria established by the ACR for diagnosis of
fibromyalgia, and must have been treated unsuccessfully with a current standard therapeutic
regimen. The criteria are (A) a history of widespread pain (in all quadrants and back) for
more than half of the days in each of the prior three months and (B) the required
number,11, of tender points of 18 test sites (indicated in Figure 1), which will be
determined during the initial physical examination (see below). They must give informed
consent to participate in this study. It is anticipated that almost all patients will be
residents of Washington, D.C. area and that they will be able to travel to NIH for
necessary preliminary studies and subsequent required evaluations. To be admitted to this
study, patients must be willing to continue using only their present medications (including
antidepressants) or other forms of care related to the control of fibromyalgia symptoms
during the course of the study. The average score on the FIQ for patients seen in tertiary
care settings is about 50 (with 100 being the maximum, a higher score indicating a greater
impairment of health) and we will include only those patients in whom the FIQ score is
greater than 30 at the initial evaluation.


Pregnant and lactating women are excluded because of the bodily changes that would occur
during the study. As indicated above, a pregnancy test will be performed in women of
childbearing age (up to age 55). The combination of widespread musculoskeletal pain, high
tender point count, and non-restorative sleep are usually sufficient criteria for the
diagnosis of fibromyalgia and the patients referred for this study will have been well
characterized in the Fibromyalgia Clinic at Georgetown University or by the referring
physician. We will, however, by history, physical examination, screening laboratory studies
and examination of the patient s medical records confirm the absence of any evidence for
peripheral neuropathies, entrapment syndromes, neurologic disorders or metabolic/endocrine
disorders, such as untreated hypothyroidism, as well as the rheumatoid disorders that might
be confused with fibromyalgia and confound the study. Patients who have abnormal screening
test results or who have traumatic or non-traumatic disorders to which pain may be
attributed. Also, patients who have a positive HIV result will be excluded. Subjects with
obviously impaired mental capacity that precludes informed consent and ability to provide
adequate self-ratings are to be excluded.
We found this trial at
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, MD
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