| Conditions: |
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Fibromyalgia |
| Purpose: |
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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
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.
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| Study Summary: |
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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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| Criteria: |
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- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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 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.
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| NCT ID: |
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NCT00366535 |
| Primary Contact: |
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Principal Investigator
Raymond A Dionne, D.D.S.
National Institute of Nursing Research (NINR)
Leorey N Saligan, C.R.N.P.
Phone: (301) 451-1685
Email: saliganl@mail.nih.gov
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| Backup Contact: |
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Email: dionner@mail.nih.gov
Raymond A Dionne, D.D.S.
Phone: (301) 496-0294
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |