Title
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
Phase
Phase 3Lead Sponsor
Mayo ClinicStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Complex Regional Pain Syndrome, Type 1Intervention/Treatment
lenalidomide ...Study Participants
7The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
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.