Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1

Mayo Clinic1 site in 1 country7 target enrollmentJuly 2005

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Complex Regional Pain Syndrome, Type 1
Sponsor: Mayo Clinic
Enrollment: 7
Locations: 1
Primary Endpoint: RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
Status: Completed
Last Updated: 15 years ago

The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

February 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

•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.