Neurotropin to Treat Fibromyalgia

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: Neurotropin	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Neurotropin Treatment of Fibromyalgia
Study Start Date :	August 2006
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: 1; Receive placebo for 12 weeks and then the active medication for 12 weeks, in random order.	Drug: Neurotropin
Active Comparator: 2; Patients will receive the active medication for 12 weeks and then the placebo for 12 weeks, in random order.	Drug: Neurotropin

Outcome Measures

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Primary Outcome Measures :

1. Relief of pain and improvement in functional capacity. [ Time Frame: 25 weeks ]

Secondary Outcome Measures :

1. Pain thresholds at specific tender points. [ Time Frame: 25 weeks. ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:	Leorey N Saligan, C.R.N.P.	National Institute of Nursing Research (NINR)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Publications:

Dworkin RH, Fields HL. Fibromyalgia from the perspective of neuropathic pain. J Rheumatol Suppl. 2005 Aug;75:1-5. Review.

Rowbotham MC. Is fibromyalgia a neuropathic pain syndrome? J Rheumatol Suppl. 2005 Aug;75:38-40. Review.

Crofford LJ. The relationship of fibromyalgia to neuropathic pain syndromes. J Rheumatol Suppl. 2005 Aug;75:41-5. Review.

Responsible Party:	National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:	NCT00366535 History of Changes
Other Study ID Numbers:	060229; 06-NR-0229
First Posted:	August 21, 2006
Last Update Posted:	September 1, 2016
Last Verified:	January 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) ):

Muscle Pain; Fibrositis Allodynia; Stiffness; Tender Points; Fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurotropin	Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anticonvulsants