Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy

NCT00120120 ↗

Phase 2/3 Completed 181 enrolled Celgene Corporation

RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of lenalidomide in the treatment of painful lumbar radiculopathy.

Timeline

Start: 2005-01
Primary completion: 2007-10
Completion: 2007-11

Outcome

Missed primary endpoint

paper no statistically significant difference in Pain Intensity-Numerical Rating Scale mean change (-0.02, P = 0.958) PMID 27550953 ↗

Publications

Manning DC, Gimbel J, Wertz R, Rauck R, Cooper A, Zeldis JB, Levinsky DM. A Phase II Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Lenalidomide in Lumbar Radicular Pain with a Long-Term Open-Label Extension Phase. Pain Med. 2017 Mar 1;18(3):477-487. doi: 10.1093/pm/pnw212.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	2 mg	Oral
Subject	Lenalidomide	Other / unclassified	5 mg	Oral