Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Celgene Corporation |
---|---|
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00067743 |
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)
Condition | Intervention | Phase |
---|---|---|
Complex Regional Pain Syndrome (RSD) |
Drug: Lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official 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) |
Enrollment: | 40 |
Study Start Date: | August 2003 |
Study Completion Date: | August 2007 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Open Label trial
|
Drug: Lenalidomide
supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day
|
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: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Center for Pain and Palliative Medicine | |
La Jolla, California, United States, 92093 | |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, North Carolina | |
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 | |
United States, Pennsylvania | |
Drexel University College of Medicine | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Washington | |
Swedish Pain Management | |
Seattle, Washington, United States, 98122-4379 |
Study Director: | Donald Manning, MD, PhD | Celgene Corporation |
Responsible Party: | Celgene Corportation ( Donald Manning, MD, PhD, Vice President Clinical Research and Development ) |
Study ID Numbers: | CC-5013-CRPS-001 |
Study First Received: | August 26, 2003 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00067743 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pain Pain syndrome Reflex sympathetic dystrophy CC-5013 |
CC5013 Revlimid Celgene CRPS |
Autonomic Nervous System Diseases Reflex Sympathetic Dystrophy Neuromuscular Diseases Complex Regional Pain Syndromes Mental Disorders |
Peripheral Nervous System Diseases Lenalidomide Reflex Sympathetic Dystrophy Syndrome Pain Somatoform Disorders |
Disease Antineoplastic Agents Nervous System Diseases Lenalidomide Pharmacologic Actions Pathologic Processes Autonomic Nervous System Diseases |
Complex Regional Pain Syndromes Neuromuscular Diseases Mental Disorders Syndrome Peripheral Nervous System Diseases Therapeutic Uses Somatoform Disorders |