Sunday, October 28, 2012

MARYLAND - fibro study recruiting participants

Note: Neurotropin® (NTP) is a nonprotein extract from inflamed skin of
rabbits inoculated with vaccinia virus and is widely used in Japan to
treat neuropathic pain such as post-herpetic neuralgia (PHN) and other
painful conditions. The principal investigator hypothesizes that
fibromyalgia is a neuropathological pain condition.

Neurotropin to Treat Fibromyalgia

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366535

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.


Contacts
Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685 saliganl@mail.nih.gov
Contact: Raymond A Dionne, D.D.S. (301) 496-0294 dionner@mail.nih.gov

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

Contact: For more information at the NIH Clinical Center contact
Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222
ext TTY8664111010 prpl@mail.cc.nih.gov

Sponsors and Collaborators
National Institute of Nursing Research (NINR)

Investigators
Principal Investigator: Raymond A Dionne, D.D.S. National Institute of
Nursing Research (NINR)

For more information:
http://clinicaltrials.gov/ct2/show/NCT00366535?term=fibromyalgia&recr=Open&rank=17

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