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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00120120
First received: July 8, 2005
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

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 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Change from baseline in RAD pain intensity ratings using PI-NRS [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (type, frequency, severity, and relationship to study drug) [ Time Frame: change from baseline ] [ Designated as safety issue: Yes ]
  • Change from baseline in the PM PI NRS value [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Change from baseline in the AM PI NRS value [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Change from baseline inactivity level rating using an NRS [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Change from baseline in SLR angle of elevation without induced pain [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Change from baseline in the SF-MPQ total score and subscale scores [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Changes from baseline in the BPI score relative to baseline pain ratings and interference scales [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Changes from baseline in the POMS total mood score and six dimension subscale scores [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Change from baseline in the PDI score [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Change from baseline in the Modified Oswestry Low Back Pain Disability Questionnaire total score [ Time Frame: change from baseline ] [ Designated as safety issue: No ]
  • Patient global impression of change [ Time Frame: change from baseline ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: January 2005
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Lenalidomide (CC-5013)
Lenalidomide 2-5 mg capsules taken one time per day
Other Name: Revlimid
Experimental: 2 Drug: Lenalidomide (CC-5013)
Lenalidomide 2-5 mg capsules taken one time per day
Other Name: Revlimid

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or greater at the time of signing the informed consent form
  • Clinical diagnosis of painful radiculopathy which is based on the presence of pain in the distribution of the sciatic nerve or L4, L5 or S1 dermatomes. The pain must be primarily in the lower leg and radiate to the ankle or foot.
  • History of painful radiculopathy involving one or both of the distal lower extremities for greater than or equal to 6 months
  • MRI or CT scan within the past 2 years or more recent if symptoms have changed
  • Positive straight leg raising (SLR) test in the index ipsilateral leg (pain radiating below the knee at an elevation of <60 degrees). In the presence of bilateral leg pain, the leg with the most severe pain will be designated the index leg.
  • Screening (Visit 1): Radiculopathy PI-NRS score must be at least 5 on an 11-point (0-10) PI-NRS
  • 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:

    1. At least eight radiculopathy PI-NRS scores during this 7-day period are required and
    2. Average radiculopathy PI-NRS score during this period must be at least 5 on an 11-point (0-10) PI-NRS.
  • Stable doses of tricyclic antidepressants, AEDs, mexiletine hydrochloride, dextromethorphan, capsaicin, NSAIDs, opioids or other medications (including prn radiculopathy medication usage) that could affect symptoms of painful radiculopathy for at least 28 days prior to randomization (Visit 2).
  • Negative drugs of abuse screen (except drugs known to be prescribed for radiculopathy).
  • Women of childbearing potential (WCBP) must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of study drug (Day 1) while on study drug (including dose interruptions) and 4 weeks after the last dose of study drug. The two methods of contraception must include one highly effective method (i.e. intrauterine device, hormonal [birth control pills, injections, or implants only if used in conjunction with a low-dose (81 mg/day) aspirin regimen], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). If a hormonal method (birth control pills, injections or implants) or IUD is not medically possible for the subject, two of the barrier methods will be acceptable.
  • Women of childbearing potential (WCBP) must have two negative pregnancy tests (sensitivity of at least 50 mlU/mL) prior to starting study drug treatment. The first test should be performed within 10-14 days and the second within 24 hours of starting study drug. Once treatment has started, it is recommended that subjects have weekly pregnancy tests during the first 4 weeks of treatment. Thereafter, subjects are required to have pregnancy testing every 4 weeks in females with regular menstrual cycles and every 2 weeks in females with irregular cycles.
  • Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study drug and for 4 weeks after the last dose of study drug.

Exclusion Criteria:

  • Pain localized in the low back or other sites that is a greater component of subject's total pain problem than lower leg and foot pain
  • Ankle or foot problems, which could interfere with the assessment of radiculopathy pain
  • Unstable lumbar spinal segment
  • Evidence of an acute operable lesion or tumor based on CT-scan or MRI results
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac or neurological disease
  • Any medical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Presence of a clinically significant psychiatric diagnosis(es) that would impair reliable study participation
  • History of deep vein thrombosis (DVT) or stroke in the past 5 years
  • History of low back or lumbar spinal surgery
  • Documented metabolic or toxic peripheral neuropathies
  • Any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from understanding or signing the informed consent form
  • White blood cell count (WBC) < 3.5 x 10/L at Visit 1
  • Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase values more than two times the upper limit of the normal range at Visit 1
  • Abnormal T3, T4 or TSH test value(s) at Visit 1 (An abnormal TSH level in the presence of normal T3 and T4 levels is acceptable).
  • More than 6 epidural steroid injections within the 12 months prior to randomization (Visit 2).
  • Use of an epidural steroid injection within 28 days of randomization
  • Concurrent use of a spinal cord stimulator or intrathecal drug infusion device
  • Limited duration (planned termination during either the Pre-randomization or Treatment Phases) non-drug therapies (including physical therapy, acupuncture and chiropractic treatments) during the Pre-randomization and Treatment Phases of the study. Subjects may continue to do home exercises, if they have been a stable part of the subject's treatment regimen for at least 28 days prior to randomization.
  • Use of concomitant medications, which could increase the risk for developing DVT, except for steroid-based contraceptives (oral, injectable, implantable) and hormone replacement therapies only if used in conjunction with a low-dose (81 mg/day) aspirin regimen
  • Use of oral corticosteroids (except for asthma inhalers and Medrol Dosepak) within 28 days prior to randomization
  • Concurrent use of thalidomide
  • Prior development of an allergic reaction/hypersensitivity, a moderate or severe rash, or any desquamation while taking thalidomide.
  • Prior treatment with lenalidomide
  • Use of any other experimental drug or therapy within 28 days of the start of the Treatment Phase
  • Current pregnancy or lactation
  • History of poor compliance or the inability to comply with medical regimens or study requirements
  • Inability to use an electronic diary
  • Active litigation (i.e. any pending litigation or pending proceeding), compensation or disability issues related to painful radiculopathy (Subjects whose cases have been settled or finally decided are eligible)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120120

  Show 23 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Victor Sloan, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Victor Sloan MD, VP Clinical R&D, Rheumatology, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00120120     History of Changes
Other Study ID Numbers: CC-5013-RAD-001
Study First Received: July 8, 2005
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Radiculopathy
Back Pain
Lumbar Pain
CC-5013
Revlimid
Lenalidomide

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 22, 2014