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

Mayo Clinic7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Complex Regional Pain Syndrome, Type 1

Interventions

LenalidamideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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