Complex Regional Pain Syndrome (RSD) Clinical Trial
— CRPSOfficial title:
A Multicenter, Open-Label Study to Evaluate the Preliminary Safety and Efficacy of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
| Verified date | December 2006 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | August 2007 |
| Est. primary completion date | October 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | UNC Hospitals University of North Carolina | Chapel Hill | North Carolina |
| United States | UCSD Center for Pain and Palliative Medicine | La Jolla | California |
| United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
| United States | Swedish Pain Management | Seattle | Washington |
| United States | The Center for Clinical Research | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | throughout the trial | No | |
| Secondary | Change in CRPS pain rating in index limb compared to baseline | throughtout trial compared to baseline | No |