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

NCT00120120 | Completed Phase 2 DMC

• 1 other identifier: CC-5013-RAD-001
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 23

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.

Conditions

Radiculopathy

Keywords

Radiculopathy; Back Pain; Lumbar Pain; CC-5013; Revlimid; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Change from baseline in RAD pain intensity ratings using PI-NRS

  baseline to week 12

Secondary Outcomes (11)

• Safety (type, frequency, severity, and relationship to study drug)

  change from baseline

• Change from baseline in the PM PI NRS value

  change from baseline

• Change from baseline in the AM PI NRS value

  change from baseline

• Change from baseline inactivity level rating using an NRS

  change from baseline

• Change from baseline in SLR angle of elevation without induced pain

  change from baseline

Study Arms (2)

1

EXPERIMENTAL

Drug: Lenalidomide (CC-5013)

2

EXPERIMENTAL

Drug: Lenalidomide (CC-5013)

Interventions

Lenalidomide (CC-5013) DRUG

Lenalidomide 2-5 mg capsules taken one time per day

Also known as: Revlimid

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• At least eight radiculopathy PI-NRS scores during this 7-day period are required and
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (23)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Genova Clinical Research, Inc

Tucson, Arizona, 85741, United States

Location

Loma Linda Institution

Loma Linda, California, 92354, United States

Location

Space Coast Neurology

Palm Bay, Florida, 32905, United States

Location

Gold Coast Research, LLC

Weston, Florida, 33331, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Rehab Institute of Chicago

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Pain Center

Baltimore, Maryland, 21205, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University Pain Mgmt Ctr

St Louis, Missouri, 63141, United States

Location

North Shore University Hospital

Bethpage, New York, 11554, United States

Location

University of Rochester Medical CenterPain Services

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Carolinas Pain Institute, P.A. & the Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Research Institute of Greater Dayton

Dayton, Ohio, 45432, United States

Location

Attn: Maryjane CerroneLehigh Valley Hospital

Allentown, Pennsylvania, 18103-6208, United States

Location

Drexel University College of MedicineDepartment of Neurology Rm 7102

Philadelphia, Pennsylvania, 19102, United States

Location

Texas Tech Medical Center Department of Anesthesiology

Lubbock, Texas, 79430, United States

Location

KRK Medical Research

Richardson, Texas, 75080, United States

Location

Fletcher Allen Healthcare for Pain Medicine

South Burlington, Vermont, 05403, United States

Location

University of Virginia Pain Management Center

Charlottesville, Virginia, 22903, United States

Location

Swedish Pain Services

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Manning DC, Gimbel J, Wertz R, Rauck R, Cooper A, Zeldis JB, Levinsky DM. 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 Med. 2017 Mar 1;18(3):477-487. doi: 10.1093/pm/pnw212.

  PMID: 27550953 DERIVED

MeSH Terms

Conditions

Radiculopathy; Back Pain; Low Back Pain

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Victor Sloan, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 15, 2005
• Study Start: January 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 23, 2009

Record last verified: 2009-09

Locations

US (23)