Clinical
Trials
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The following new clinical trials
are being conducted by the National Institute of Health (NIH)
in Bethesda, MD.
Please click
on the links below to view more information regarding these studies.
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The following new clinical trial
is for patients who suffer from CRPS Type I.
Medical Research
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the
Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional
Pain Syndrome Type I.
Sponsored by: Celgene Corporation
Purpose
This is a multi-center, double blind, placebo-controlled study in adult
subjects with Complex Regional Pain Syndrome (CRPS) Type
I .
One hundred eighty (180) subjects diagnosed with unilateral CRPS Type
I will be enrolled and randomized to receive
orally either 10mg per day of Lenalidomide or placebo (90 subjects per
treatment). For each subject, the subject consists of three phases.
Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and
Extension Phase (up to 52 weeks).
|
Condition |
Treatment or Intervention |
Phase |
|
Complex Regional Pain Syndrome (RSD) Type
I |
Drug: Lenalidomide |
Phase II |
|
Study Type |
Interventional |
|
Study Design |
Multicenter, Randomized, Double-Blind,
Placebo-Controlled, Single Group Assignment, Safety/Efficacy Study. |
Further Study Details
|
Expected Total Enrollment |
180 |
|
Study start |
January, 2005 |
|
Study completion |
January, 2007 |
Eligibility
|
Ages Eligible for Study |
18 years and above |
|
Genders Eligible for Study |
Both |
Criteria
Inclusion Criteria
 |
Age ›18 years at the time of signing the informed consent
form |
 | Understand and voluntarily sign an informed consent form
|
|
|
A diagnosis of CRPS Type I as defined by
modified International Association for the Study of Pain criteria for at
least one-year duration. Unilateral involvement of a distal limb (hand
or foot) with or without proximal spread must be present. In the
presence of upper and lower limb involvement, the most severely affected
limb will be designated the CRPS-affected limb. |
| Screening (Visit 1): CRPS pain intensity score in the CRPS-affected
limb
must be at least 4 on an 11-point (0-10) PI-NRS |
| Measurable (by electrophysiology methods) sural, median sensory,
median motor and peroneal motor nerves at the screening nerve
conduction study. |
| Opioid analgesics, non-opioid analgesics, non-steroidal
anti-inflammatory drugs, anticonvulsants, antidepressant drugs and other
non-drug therapies may be continued provided that the subject is on
stable doses/regimens for at least four weeks prior to the start of the
Treatment Phase (Visit 2). |
| Able to adhere to the study visit schedule and other protocol
requirements. |
| Women of childbearing potential (WCBP) must have a negative serum or
urine pregnancy test within 7 days of starting study drug. In addition,
sexually active WCBP must agree to use adequate contraceptive methods (tubal
ligation; intra-uterine device; barrier contraceptive with spermicide;
or vasectomized partner) while on study drug. The use of
steroid-based contraceptives (oral, injectable or implanted) is not
permitted in this study. WCBP must agree to have pregnancy tests
every 4 weeks while on study drug.
 | A woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been
naturally postmenopausal for at least 24 consecutive months (i.e., who
has had menses at any time in the preceding 24 consecutive months).
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Exclusion Criteria
The presence of any of the following will exclude a subject from study
enrollment:
| History of deep vein thrombosis (DVT) or stroke in the past 5 years.
|
| Documented peripheral neuropathies to include diabetic neuropathy
and other metabolic or toxic neuropathies. |
| Current signs or symptoms of severe, progressive or uncontrolled
renal,
hepatic, hematological, endocrine, pulmonary, cardiac, neurological or
cerebral disease. |
| Any other serious medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from signing the
informed consent form. |
| White blood cell count (WBC) < 3.5 x 109 / L at Visit 1.
|
| Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)
or
alkaline phosphatase levels more than two times the upper limit of the
normal range at Visit 1. |
| Abnormal thyroid function test values at Visit 1. |
| Any condition, including the presence of laboratory abnormalities,
which places the subject at unacceptable risk if he/she were to
participate in the study or confounds the ability to interpret data from
the study. |
| Use of concomitant medication(s), including steroid-based
contraceptives (oral, injectable or implanted) and hormone replacement
therapies which could increase the risk for developing DVT. |
| Concurrent use of thalidomide. |
| Prior development of an allergic reaction/hypersensitivity while
taking
thalidomide. |
| Prior development of a moderate or severe rash or any desquamation
while taking thalidomide. |
| Prior treatment with Lenalidomide. |
| If you feel you meet the above criteria for inclusion in this study
and are interested in participating or would like more information
please contact Space Coast
Neurology in Palm Bay, Florida at: (321) 984-7997.
Dr. Hashmi, the study investigator or Pauline Cobble the site
coordinator will be more than happy to assist you.
Please visit Space Coast Neurology website at:
www.rsdconsultants.com
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The following two clinical trials are being conducted at the National
Institute of Health (NIH) in Bethesda, MD, for patients who suffer from RSD/CRPS.
Study of Proteins Associated with
Complex Regional Pain Syndrome
This study is currently recruiting patients
Sponsored by:
National Institute of Dental and Craniofacial Research (NIDCR)
For more information please contact:
National Institute of Dental And Craniofacial Research (NIDCR)
9000 Rockville Pike,
Bethesda, Maryland, 20892 USA
Patient Recruitment and Public Liaison Office 800-411-1222
TTY 866-411-1010
prpl@mail.cc.nih.gov
Please click on the link below for
information regarding this clinical trial
http://clinicaltrials.gov/ct/show/NCT00033969?order=1 |
Neurotropin to Treat
Acute Dental
and Chronic Neural Pain
This study is currently recruiting patients
Sponsored by:
National Institute of Dental and
Craniofacial Research (NIDCR)
For more information please contact:
National Institute of Dental And Craniofacial Research (NIDCR)
9000 Rockville Pike,
Bethesda, Maryland, 20892 USA
Patient Recruitment and Public Liaison Office 800-411-1222
TTY 866-411-1010
prpl@mail.cc.nih.gov
Please click on the link below for
information regarding this clinical trial
http://clinicaltrials.gov/ct/show/NCT00006289?order=2 |
*For more information regarding
current and future clinical trials please visit: http://clinicaltrials.gov/
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changing, or stopping any treatments or medicines consult your physician.
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expressed written permission from the owner; Copyright ©1996-2010 Eric M. Phillips- Last Update
6/19/2009 |
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