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

Radiculopathy Clinical Trial

Official title: A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy

Status Completed

Clinical Trial 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.

Clinical Trial Description

Study Duration: Pre-randomization Phase: 14 days; Treatment Phase: 12 weeks; Extension Phase: Ongoing; Total Study Duration: Up to 14 weeks + the duration of the extension phase

For each subject, the study consists of three phases: Pre-randomization phase (14 days), Treatment Phase (12 weeks) and an extension phase where subjects have the opportunity to receive lenalidomide treatment as long as benefit is derived from the drug. Subjects who complete all 12 weeks of the treatment phase may be eligible to initiate (subjects randomized to receive placebo in the treatment phase) or continue to receive lenalidomide therapy (subjects randomized to receive lenalidomide in the treatment phase) in the extension phase. Subjects may continue in the extension phase as long as a benefit is derived from the drug. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiculopathy

• NCT number: NCT00120120
• Study type: Interventional
• Source: Celgene
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2005
• Completion date: November 2007