Complex Regional Pain Syndrome, Type 1 Clinical Trial
Official title:
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
| Verified date | March 2011 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | February 2009 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Age > or = to 18 years 2. Signed consent form 3. A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb 4. CRPS pain intensity score at least 4 on an 11-point PI-NRS 5. Measurable sural, median sensory, median motor and peroneal motor nerve conductions 6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | Elgene Chemical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline |