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.

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.