Re: New Fibromyalgia Study? & Med?

Sorry for bringin this one back into action (lol, what action??!!) but
I was hopin' that Kim (prn) or Debs or ..all w/RSD or Neuropathy might
see it Along w/ All of us who also have cmp/fms.
Anyway, for better or worse here it is! Anyone try the drug
Neurotropin for RSD?
Kindly,
LoriBoB



On May 24, 10:01 am, "LoriB.o.B." <banjob...@xxxxxxxxxxx> wrote:
Hi there folks!
Say, I've been doin a bunch of searches on RSD/Neuropathy & I found
this study on FMS on one of the RSD sites. Looked interesting tho I
only perused it (lol, now I need to check the date on it to see how
"new" it is!) so sorry if it isn't "New"! Also, I hadn't heard of the
drug Neurotropin to treat RSD/Neuropathy/Neuralgia pain. Anyone have
any experiences w/it?
Thanks! Hope everyone is doin' as well as can be & sleepin' well
too! (ha, we can wish, right?!)
Kindly,
LoriBoB
**************
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NIH Clinical Research Studies

Protocol Number: 06-NR-0229
Active Accrual, Protocols Recruiting New Patients

Title:
Neurotropin Treatment of Fibromyalgia

Number:
06-NR-0229

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.

Sponsoring Institute:
National Institute of Nursing Research (NINR)

Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

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 which will be
determined
during the initial physical examination. 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
nonrestorative
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.

Special Instructions:

Currently Not Provided

Keywords:
Muscle Pain
Fibrositis Allodynia
Stiffness
Tender Points

Recruitment Keyword(s):
Fibromyalgia

Condition(s):
Fibromyalgia

Investigational Drug(s):
Neurotropin

Investigational Device(s):
None

Intervention(s):
Drug: Neurotropin

Supporting Site:
National Institute of Nursing Research

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:p...@xxxxxxxxxxxxxxx

Citation(s):
Dworkin RH, Fields HL. Fibromyalgia from the perspective of
neuropathic
pain. J Rheumatol Suppl. 2005 Aug;75:1-5. Review. No abstract
available.

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.

Active Accrual, Protocols Recruiting New Patients

If you have:

* Questions about participating in a study, please contact the
Patient
Recruitment and Public Liaison Office, CC.
* Technical questions regarding the Clinical Center web site,
please contact
the Department of Networks and Applications, CC.

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Home Opinions Press Releases Link Categories J-EAST
TOP > J-EAST > List of Journal Titles (J) > Journal of Clinical
Therapeutics & Medicines(2002) > Effect of Neurotropin tablets for the
treatment of Herpes zoster. Clinical evaluation of early treatment.
Effect of Neurotropin tablets for the treatment of Herpes zoster.
Clinical evaluation of early treatment.
Accession number;03A0050349
Title;Effect of Neurotropin tablets for the treatment of Herpes
zoster. Clinical evaluation of early treatment.
Author;TAKEMURA TSUKASA(Shikiekimaehifuka) IMAGAWA ICHIRO
UCHIGASAKI SHUKO ONISHI YOSHIHIRO NAGAMURA YOZO HAGANE SHIGEKI
MAEOKA JINTETSU FURUI YOSHIHIKO WATANABE HAJIME
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.18;NO.11;PAGE.1255-1263(2002)
Figure&Table&Reference;FIG.5, TBL.3, REF.11
Pub. Country;Japan
Language;Japanese
Abstract;Antiviral agents and others in addition to NSAIDs and nerve
blocking agents have been used for the treatment of herpes zoster. To
avoid subsequent onset of postherpetic neuralgia, sufficient treatment
of pain in the earlier period is considered important. In this study,
Neurotropin tablet, the sole drug approved for the treatment of
postherpetic neuralgia in Japan, was examined for efficacy in treating
pain of the patients with herpes zoster. The drug was given twice
daily (2 tablets each) in the morning and evening for 4 weeks or
longer. Skin symptoms and pain were examined for symptom disappearance
and judged by the Kaplan & Meier estimation method. Global
improvement, safety, and usefulness were also judged. The number of
subjects was 39, comprising 25 males (64.1%) and 14 females (35.9%).
Those aged at 60 years old or more accounted for more than half (21
subjects, 53.8%), and average age was 59.1 years old. Severity of
herpes zoster was Moderate in 31 subjects (79.5%), and Severe and Mild
each in 4 (each 10.3%). Regarding details of the pain, "Pricking pain"
predominated, accounting for 51.3% (20 subjects), "Dull pain"
accounted for 33.3% (13), and "Burning pain" accounted for 7.7% (3),
and it was revealed that a sign of neuropathic pain was already
confirmed in the early stage. Aciclovir was concomitantly given to 35
subjects (89.7%) and NSAIDs were given to 7 subjects (17.9%).Pain
disappeared in 25 subjects (64.1%), although some pain-associated
symptoms persisted in 14 subjects (35.9%). In a follow-up study, 25
subjects answered the questionnaire, and persistent pain was
complained of by only 1 subject (4.0%), showing good results of
Neurotropin tablet in preventing transition from herpes zoster to
postherpetic neuralgia. Global improvement rate was high, 94.9%
(37/39), and no side effects were confirmed. It is concluded that
Neurotropin tablet is an excellent and valuable drung for the pain
control of herpes zoster in the acute stage. (author abst.)
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