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.
OBJECTIVE: This phase II study assessed lenalidomide efficacy and safety.
DESIGN: Three-phase core study: 14-day prerandomization, 12-week treatment, and 52-week open-label extension.
SETTING: Fourteen US centers from July 2005 to July 2007.
SUBJECTS: Chronic lumbar radicular pain patients without history of nerve injury or deficit.
METHODS: Subjects were randomized (1:1) to double-blind treatment with lenalidomide 10 mg or placebo once daily for 12 weeks, followed by a 52-week open-label extension. A 12-week, single-center, randomized-withdrawal (1:2, lenalidomide:placebo), exploratory study with open-label extension was undertaken in 12 subjects from the core extension who were naïve to neuropathic medications and with at least a two-point decrease from baseline average daily Pain Intensity-Numerical Rating Scale score.
RESULTS: Of 180 subjects enrolled, 176 had at least one postbaseline measure; 132 completed the 12-week treatment phase. In the core study, no statistically significant difference in Pain Intensity-Numerical Rating Scale mean change (-0.02, P = 0.958) was observed at week 12 between lenalidomide and placebo; proportions achieving pain reduction at week 12 and other secondary measures were comparable between lenalidomide and placebo. In the exploratory study, week 12 mean changes in Pain Intensity-Numerical Rating Scale scores were -0.05 (lenalidomide: N = 3) and 2.11 (placebo: N = 8). Mean changes in Brief Pain Inventory-short form interference scores were -3.33 and 8.38, respectively; scores at six months were maintained or decreased in 10 of 12 subjects.
CONCLUSIONS: While this study does not support lenalidomide use in an unselected lumbar radicular pain population, an immunomodulating agent may relieve pain in select subjects naïve to neuropathic pain medications.ClinicalTrials.gov identifier: NCT00120120.
Published In/Presented At
Manning, D. C., Gimbel, J., Wertz, R., Rauck, R., Cooper, A., Zeldis, J. B., & Levinsky, D. M. (2016). 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 Medicine (Malden, Mass.),
Anesthesiology | Medicine and Health Sciences
Department of Anesthesiology