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.
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 April 17, 2014
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases