Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1

Phase 2 Terminated 184 enrolled Celgene Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.

Timeline

Start: 2005-02
Primary completion: 2008-04
Completion: 2008-04

Outcome

Missed primary endpoint

Stopped: “Interim analysis showed the primary outcome was not reached”

paper The primary endpoint was not met because equal proportions of treated (16.1%) and control (16.1%) subjects achieved the outcome; PMID 25283471 ↗

Publications

Manning DC, Alexander G, Arezzo JC, Cooper A, Harden RN, Oaklander AL, Raja SN, Rauck R, Schwartzman R. Lenalidomide for complex regional pain syndrome type 1: lack of efficacy in a phase II randomized study. J Pain. 2014 Dec;15(12):1366-76. doi: 10.1016/j.jpain.2014.09.013. Epub 2014 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	10 mg	Oral