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

Phase 3

Completed

• Conditions: Complex Regional Pain Syndrome, Type 1

• Registration Number: NCT00166452
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2007-04
• Study Completion: 2009-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States