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

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00120120

Collaborator

(none)

181

Enrollment

Locations

Arms

Duration (Months)

7.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy	Drug: Lenalidomide (CC-5013)	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

181 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Lenalidomide (CC-5013) Lenalidomide 2-5 mg capsules taken one time per day Other Names: Revlimid
Experimental: 2	Drug: Lenalidomide (CC-5013) Lenalidomide 2-5 mg capsules taken one time per day Other Names: Revlimid

Arm

Intervention/Treatment

Experimental: 1

Drug: Lenalidomide (CC-5013)

Lenalidomide 2-5 mg capsules taken one time per day

Other Names:

Revlimid

Experimental: 2

Drug: Lenalidomide (CC-5013)

Lenalidomide 2-5 mg capsules taken one time per day

Other Names:

Revlimid

Outcome Measures

Primary Outcome Measures

Change from baseline in RAD pain intensity ratings using PI-NRS [baseline to week 12]

Secondary Outcome Measures

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]
Change from baseline in the SF-MPQ total score and subscale scores [change from baseline]
Changes from baseline in the BPI score relative to baseline pain ratings and interference scales [change from baseline]
Changes from baseline in the POMS total mood score and six dimension subscale scores [change from baseline]
Change from baseline in the PDI score [change from baseline]
Change from baseline in the Modified Oswestry Low Back Pain Disability Questionnaire total score [change from baseline]
Patient global impression of change [change from baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Research Center	Phoenix	Arizona	United States	85023
2	Genova Clinical Research, Inc	Tucson	Arizona	United States	85741
3	Loma Linda Institution	Loma Linda	California	United States	92354
4	Space Coast Neurology	Palm Bay	Florida	United States	32905
5	Gold Coast Research, LLC	Weston	Florida	United States	33331
6	Emory University Hospital	Atlanta	Georgia	United States	30322
7	Rehab Institute of Chicago	Chicago	Illinois	United States	60611
8	University of Iowa	Iowa City	Iowa	United States	52242
9	Johns Hopkins Pain Center	Baltimore	Maryland	United States	21205
10	Mayo Clinic	Rochester	Minnesota	United States	55905
11	Washington University Pain Mgmt Ctr	St. Louis	Missouri	United States	63141
12	North Shore University Hospital	Bethpage	New York	United States	11554
13	University of Rochester Medical CenterPain Services	Rochester	New York	United States	14642
14	Duke University Medical Center	Durham	North Carolina	United States	27705
15	Carolinas Pain Institute, P.A. & the Center for Clinical Research, LLC	Winston Salem	North Carolina	United States	27103
16	Research Institute of Greater Dayton	Dayton	Ohio	United States	45432
17	Attn: Maryjane CerroneLehigh Valley Hospital	Allentown	Pennsylvania	United States	18103-6208
18	Drexel University College of MedicineDepartment of Neurology Rm 7102	Philadelphia	Pennsylvania	United States	19102
19	Texas Tech Medical Center Department of Anesthesiology	Lubbock	Texas	United States	79430
20	KRK Medical Research	Richardson	Texas	United States	75080
21	Fletcher Allen Healthcare for Pain Medicine	South Burlington	Vermont	United States	05403
22	University of Virginia Pain Management Center	Charlottesville	Virginia	United States	22903
23	Swedish Pain Services	Seattle	Washington	United States	98104