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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Open Label trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | throughout the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CRPS pain rating in index limb compared to baseline | throughtout trial compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Manning, MD, PhD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Center for Pain and Palliative Medicine | La Jolla | California | 92093 | United States | ||
| Johns Hopkins Hospital |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D010146 | Pain |
| D013001 | Somatoform Disorders |
| D012019 | Reflex Sympathetic Dystrophy |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| UNC Hospitals University of North Carolina | Chapel Hill | North Carolina | 27599-7010 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| Swedish Pain Management | Seattle | Washington | 98122-4379 | United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |