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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Celgene Corporation

Current Primary Outcome: Change from baseline in RAD pain intensity ratings using PI-NRS [ Time Frame: baseline to week 12 ]

Original Primary Outcome:

Current Secondary Outcome:

  • Safety (type, frequency, severity, and relationship to study drug) [ Time Frame: change from baseline ]
  • Change from baseline in the PM PI NRS value [ Time Frame: change from baseline ]
  • Change from baseline in the AM PI NRS value [ Time Frame: change from baseline ]
  • Change from baseline inactivity level rating using an NRS [ Time Frame: change from baseline ]
  • Change from baseline in SLR angle of elevation without induced pain [ Time Frame: change from baseline ]
  • Change from baseline in the SF-MPQ total score and subscale scores [ Time Frame: change from baseline ]
  • Changes from baseline in the BPI score relative to baseline pain ratings and interference scales [ Time Frame: change from baseline ]
  • Changes from baseline in the POMS total mood score and six dimension subscale scores [ Time Frame: change from baseline ]
  • Change from baseline in the PDI score [ Time Frame: change from baseline ]
  • Change from baseline in the Modified Oswestry Low Back Pain Disability Questionnaire total score [ Time Frame: change from baseline ]
  • Patient global impression of change [ Time Frame: change from baseline ]


Original Secondary Outcome:

Information By: Celgene

Dates:
Date Received: July 8, 2005
Date Started: January 2005
Date Completion:
Last Updated: September 22, 2009
Last Verified: September 2009