AWARENESS OPPORTUNITY

In May, there will be a concert in Michigan to raise money for CRPS/RSD awareness and research.

Mr. James, the songwriter and performer "is trying to put together a slide show movie of people with CRPS/RSD...something that will be very moving and show the really human and very real side of this syndrome ......I need about 60-90 pictures of people with RSDS holding up a standard white poster board from like Staples and then painted (or a big marker)...stating something like "I've lived with RSDS for 10 years" or however long...or "my name is so and so and RSDS affects me everyday".....you get the idea...it can say whatever they want about the disease and how it affects them or how long they've had it or how they feel about it...or ...whatever they like to get across in the picture...I will put them all together with music and narration to make this slide show movie...."

"So I'm requesting ...could you help me track down some of these pictures?...or ask RSDS patients that you know to send them in......Tiffany (my friend with RSDS) has tried through forums and has not been getting a response.....Thanks for your help in advance."


Sincerely,
Brian James
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Celgene launches national clinical trial of Lenalidomide for CRPS
Please help us spread the word.
Best of health, Jim Broatch

Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1

Sponsored by: Celgene Corporation

Information provided by: Celgene Corporation

Purpose

This is a multicenter, double-blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.
One hundred eighty (180) subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mg/day of lenalidomide or placebo (90 subjects per treatment arm). For each subject, the study 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 1 Drug: Lenalidomide Phase II

MedlinePlus related topics: Reflex Sympathetic Dystrophy

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 1 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
Randomization (Visit 2): Average PI-NRS score for randomization
purposes (Visit 2) will be based on AM and PM assessments made during the 7 days prior to randomization:
At least eight PI-NRS scores during this 7-day period are
required and
Average PI-NRS score in the CRPS-affected limb during this
period 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).
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.
Location Information (United States)

Arizona Pivotal Research Centers, Peoria, Arizona 85381
California Loma Linda Institution, Loma Linda, California, 92354
  UCSD Center for Pain and Palliative Medicine, La Jolla, California, 92093,
Florida Space Coast Neurology, Palm Bay, Florida 32905
Illinois Rehab Institute of Chicago, Chicago, Illinois, 60611
Iowa University of Iowa, Iowa City, Iowa, 52242
Maryland Johns Hopkins Hospital, Baltimore, Maryland 21287
Massachusetts Baystate Medical Center, Springfield, Massachusetts, 01199,
  Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115

Minnesota
 Mayo Clinic, Rochester, Minnesota 55905
Missouri Washington University Pain Management Center, St. Louis, Missouri 63141
New York Hospital for Joint Disease, New York, New York, 10003
North Carolina Carolinas Pain Institute, P.A. & The Center for Clinical Research, LLC,
Winston-Salem, North Carolina, 27108
  Duke University Medical Center, Durham, North Carolina, 27705
  UNC Hospitals University of North Carolina, Chapel Hill, North Carolina, 27599
  Womack Army Medical Center, Fort Bragg, North Carolina 28310
Oregon Oregon Health & Science University, Portland, Oregon, 97239
Pennsylvania Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102
  Knobler Institute of Neurologic Disease, Ft. Washington, Pennsylvania, 19034
Texas Texas Tech Medical Center, Lubbock, Texas, 79430
Virginia University of Virginia Pain Management Center, Charlottesville, Virginia,
22903
Washington Swedish Pain Services, Seattle, Washington, 98104

 

More Information

Study ID Number: CC-5013-CRPS-002
Record last reviewed:
Last Updated:
Record first received:
ClinicalTrials.gov Identifier:
Health Authority: United States: Food and Drug Administration.

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