A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
- Registration Number
- NCT00067743
- Lead Sponsor
- Celgene Corporation
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Lenalidomide Open Label trial
- Primary Outcome Measures
Name Time Method Safety throughout the trial
- Secondary Outcome Measures
Name Time Method Change in CRPS pain rating in index limb compared to baseline throughtout trial compared to baseline
Trial Locations
- Locations (6)
Swedish Pain Management
🇺🇸Seattle, Washington, United States
UNC Hospitals University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
UCSD Center for Pain and Palliative Medicine
🇺🇸La Jolla, California, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
The Center for Clinical Research
🇺🇸Winston Salem, North Carolina, United States