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Lenalidomide for complex regional pain syndrome type 1: lack of efficacy in a phase II randomized study
Journal article   Open access   Peer reviewed

Lenalidomide for complex regional pain syndrome type 1: lack of efficacy in a phase II randomized study

Donald C Manning, Guillermo Alexander, Joseph C Arezzo, Alyse Cooper, R Norman Harden, Anne Louise Oaklander, Srinivasa N Raja, Richard Rauck and Robert Schwartzman
The journal of pain, v 15(12), pp 1366-1376
Dec 2014
DOI: https://doi.org/10.1016/j.jpain.2014.09.013
PMID: 25283471
Featured in Collection :   UN Sustainable Development Goals @ Drexel
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https://doi.org/10.1016/j.jpain.2014.09.013View
Published, Version of Record (VoR)CC BY-NC-ND V4.0,  Open

Abstract

Aged Analgesics, Non-Narcotic - adverse effects Analgesics, Non-Narcotic - therapeutic use Chronic Disease Double-Blind Method Female Humans Male Middle Aged Reflex Sympathetic Dystrophy - drug therapy Reflex Sympathetic Dystrophy - physiopathology Thalidomide - adverse effects Thalidomide - analogs & derivatives Thalidomide - therapeutic use Treatment Outcome
Complex regional pain syndrome (CRPS) is a potentially debilitating chronic pain syndrome with a poorly understood but likely neuroimmune/multifactorial pathophysiology associated with axonal injury. Based on the potential contribution of proinflammatory cytokines to CRPS pathogenesis and prior research with thalidomide, we investigated lenalidomide, a thalidomide derivative, for CRPS treatment. We conducted a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral lenalidomide 10 mg once daily in consenting patients with unilateral or bilateral CRPS type 1. The study comprised 12 weeks of treatment followed by a long-term extension. The primary efficacy outcome was reduced pain in the index limb, defined as ≥30% improvement from baseline using an 11-point numeric rating scale. One hundred eighty-four subjects enrolled. The primary endpoint was not met because equal proportions of treated (16.1%) and control (16.1%) subjects achieved the outcome; however, lenalidomide was well tolerated, with no evidence of neuropathy or major adverse effects. This study is the largest controlled, blinded clinical trial in subjects with chronic CRPS using the Budapest research criteria. It demonstrates the feasibility of conducting high-quality clinical trials in CRPS type 1 and provides considerations for designing future trials. This article reports an adequately powered, controlled clinical trial in subjects with CRPS. Treatment and placebo were equally effective, but the study demonstrated that lenalidomide treatment is feasible in this population. The study provides examples to consider in designing future CRPS trials.

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20 citations in Web of Science
25 citations in Scopus

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Industry collaboration
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Web of Science research areas
Clinical Neurology
Neurosciences
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