Trial record 3 of 90 for:
Complex Regional Pain Syndrome
A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
This study has been completed.
Information provided by:
First received: August 26, 2003
Last updated: December 28, 2007
Last verified: December 2006
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)
Complex Regional Pain Syndrome (RSD)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multicenter, Open-Label Study to Evaluate the Preliminary Safety and Efficacy of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
Primary Outcome Measures:
- Safety [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in CRPS pain rating in index limb compared to baseline [ Time Frame: throughtout trial compared to baseline ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2004 (Final data collection date for primary outcome measure)
Open Label trial
supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day
Other Name: Revlimid
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067743
|UCSD Center for Pain and Palliative Medicine
|La Jolla, California, United States, 92093 |
|Johns Hopkins Hospital
|Baltimore, Maryland, United States, 21287 |
|UNC Hospitals University of North Carolina
|Chapel Hill, North Carolina, United States, 27599-7010 |
|The Center for Clinical Research
|Winston Salem, North Carolina, United States, 27103 |
|Drexel University College of Medicine
|Philadelphia, Pennsylvania, United States, 19102 |
|Swedish Pain Management
|Seattle, Washington, United States, 98122-4379 |
||Donald Manning, MD, PhD
No publications provided
||Donald Manning, MD, PhD, Vice President Clinical Research and Development, Celgene Corportation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 26, 2003
||December 28, 2007
||United States: Food and Drug Administration
Keywords provided by Celgene Corporation:
Reflex sympathetic dystrophy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases