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Sponsored by: |
Celgene Corporation |
---|---|
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00120120 |
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.
Condition | Intervention | Phase |
---|---|---|
Radiculopathy |
Drug: Lenalidomide (CC-5013) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy |
Estimated Enrollment: | 180 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Randomization (Visit 2): Average radiculopathy PI-NRS score for randomization purposes will be based on AM and PM assessments made during the 7 days prior to randomization:
Exclusion Criteria:
Study ID Numbers: | CC-5013-RAD-001 |
Study First Received: | July 8, 2005 |
Last Updated: | May 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00120120 |
Health Authority: | United States: Food and Drug Administration |
Radiculopathy Back Pain Lumbar Pain |
CC-5013 Revlimid Lenalidomide |
Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Lenalidomide |
Low Back Pain Pain Back Pain |
Antineoplastic Agents Therapeutic Uses Nervous System Diseases Pharmacologic Actions |