A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Elgene Chemical

Criteria

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.