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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day
UCSD Center for Pain and Palliative Medicine
La Jolla, California, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
UNC Hospitals University of North Carolina
Chapel Hill, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Safety
Time frame: throughout the trial
Change in CRPS pain rating in index limb compared to baseline
Time frame: throughtout trial compared to baseline
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Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Swedish Pain Management
Seattle, Washington, United States