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

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

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Key information

Conditions

Complex Regional Pain Syndrome, Type 1 Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lenalidamide

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Elgene Chemical

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2009
First posted: Sep 14, 2005
Registry last updated: Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed