A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)

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.