Status:
COMPLETED
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Elgene Chemical
Conditions:
Complex Regional Pain Syndrome, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \> or = to 18 years
- Signed consent form
- A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
- CRPS pain intensity score at least 4 on an 11-point PI-NRS
- Measurable sural, median sensory, median motor and peroneal motor nerve conductions
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00166452
Start Date
July 1 2005
End Date
February 1 2009
Last Update
March 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905