International Research Foundation for RSD / CRPS

 

MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LENALIDOMIDE IN THE TREATMENT OF COMPLEX REGIONAL PAIN SYNDROME TYPE 1

 

Two members of the Foundation's Scientific Advisory Committee are Principal Investigators in the following well-controlled clinical trial on lenalidomide in patients with RSD / CRPS.

Preliminary results from research on lenalidomide are encouraging. Celgene recently amended the protocol to include bilateral as well as unilateral subjects and they are also looking into the possibility of adding on some additional sites.

 

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).

 
 
 

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:
    a. At least eight PI-NRS scores during this 7-day period are
    required and
    b. 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 in the non-affected limb 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.

 

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

 

 
 

State

Principal Investigator

Institution

Arizona

Dr.Louis Kirby, 623-815-9714

Pivotal Research Centers, Peoria, Arizona 85381

California

Dr. Lowell Reynolds
909-558-6280

Loma Linda Institution, Loma Linda, California, 92354

 

Dr. Mark Wallace
858-647-7030



UCSD Center for Pain and Palliative Medicine, La Jolla, California, 92093

Florida

Dr.Masood Hashmi
321-984-7997

Space Coast Neurology, Palm Bay, Florida 32905

Illinois

Dr.Norman Harden
312-238-7878

Rehab Institute of Chicago, Chicago, Illinois, 60611


Iowa

Dr Richard Rosenquist
319-365-2633

University of Iowa, Iowa City, Iowa, 52242


Maryland

 

Dr. Srinivasa Raja
410-955-1822

Johns Hopkins Hospital, Baltimore, Maryland, 21287

Massachusetts

Dr. Robert Steinberg
413-794-3520

Baystate Medical Center, Springfield, Massachusetts, 01199

 

Dr. Zahid Bajwa
617-667-4505

Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115

Minnesota

Dr. Keith Bengtson
507-284-4363

Mayo Clinic, Rochester, Minnesota, 55905

Missouri

Dr. Anthony Guarino
314-996-8887

Washington University Pain Management Center, St. Louis, Missouri, 63141

New York

Dr. Harry Shen
212-598-6091

Hospital for Joint Disease, New York, New York, 10003

North Carolina

Dr. Richard Rauck

336-765-6181

Carolinas Pain Institute, P.A. & The Center for Clinical Research, LLC,
Winston-Salem, North Carolina, 27108

 

Dr. Veeraindar Goli
919-684-1350

Duke University Medical Center, Durham, North Carolina, 27705

 

Dr. Sunil Dogra
919-966-7505

UNC Hospitals University of North Carolina, Chapel Hill, North Carolina, 27599

 

Dr. Christopher Grubb
910-907-8869

Womack Army Medical Center, Fort Bragg, North Carolina 28310

Oregon

Dr. Brett Stacey
503-494-5370

Oregon Health & Science University, Portland, Oregon, 97239

Pennsylvania

Dr. Robert Schwartzman
215-762-7090

Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102

 

Dr. Robert Knobler
215-643-9045

Knobler Institute of Neurologic Disease, Ft. Washington, Pennsylvania, 19034

 

Dr. Robert Wertz
610-402-2273

Lehigh Valley Hospital

Allentown, PA 18103

Texas

Dr. Gabor Racz
806-743-2983

Texas Tech Medical Center, Lubbock, Texas, 79430


Virginia

Dr. Robin Hamill-Ruth 434-243-5676

University of Virginia Pain Management Center, Charlottesville, Virginia
22903

Washington

Gordon Irving
206-215-2537

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: NCT00109772

Health Authority: United States: Food and Drug Administration

 

 

Interested persons need to e-mail Alyse Cooper at

acooper@celgene.com

 

 

 

 

 

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