| 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 |
| |
| |
| 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 |