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A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
This study has been completed.
Study NCT00067743   Information provided by Celgene Corporation
First Received: August 26, 2003   Last Updated: December 28, 2007   History of Changes

August 26, 2003
December 28, 2007
August 2003
October 2004   (final data collection date for primary outcome measure)
Safety [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00067743 on ClinicalTrials.gov Archive Site
Change in CRPS pain rating in index limb compared to baseline [ Time Frame: throughtout trial compared to baseline ] [ Designated as safety issue: No ]
Same as current
 
A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
A Multicenter, Open-Label Study to Evaluate the Preliminary Safety and Efficacy of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)

This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)

Once the subject completes the 12 week treatment phase the subject is eligible to continue on the trial. Subjects may continue until no further benefit is obtained.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Complex Regional Pain Syndrome (RSD)
Drug: Lenalidomide
Other: Open Label trial
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
August 2007
October 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of Type 1 CRPS as defined by modified International Association for the Study of Pain criteria (App 1) for at least one year duration
  • Unilateral involvement of a distal hand or foot with or without proximal speed must be present. The most severely affected limb will be designated the index limb.
  • CRPS pain severity score in the index limb of 4 or greater on an 11-point (0-10) NRS (Appendix I).
  • Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants and antidepressant drugs may be continued provided that the subject was on stable doses for at least four weeks prior to the Treatment phase.
  • Understand and voluntarily sign an informed consent form
  • 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 (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
  • WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
  • The average CRPS pain severity score in the index limb at the end of the Pre-Treatment Phase I (must be 4 or greater) and 2 each of the daily scores over the week must be within +/- one point of this average.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Prior treatment with CC-5013
  • Prior development of an allergic reaction/hypersensitivity while taking thalidomide.
  • Prior development of a moderate or sever rash or any desquamation while taking thalidomide.
  • Pregnant or lactating females.
  • Active litigation, compensation or disability issues related to CRPS.
  • 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 any other experimental drug or therapy within 28 days of the treatment phase.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067743
Donald Manning, MD, PhD, Vice President Clinical Research and Development, Celgene Corportation
CC-5013-CRPS-001
Celgene Corporation
 
Study Director: Donald Manning, MD, PhD Celgene Corporation
Celgene Corporation
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP