Neurotropin Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Placebo; Neurotropin
Intervention description: 4 tabs b.i.d.; 4 tabs b.i.d.
Intervention MeSH terms: Neurotropin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Muscle Pain; Fibrositis Allodynia; Stiffness; Tender Points; Fibromyalgia

Summary:

      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.
    

Eligibility criteria:

        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 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.