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RadiculopathyPhase 2/3NCT00120120

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

A Phase 2/3 study testing Lenalidomide (CC-5013) in people with Radiculopathy, run by Celgene Corporation at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Radiculopathy
What is being tested?
Lenalidomide (CC-5013)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
23 sitesUnited States
Study dates
Jan 2005to Nov 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Attn: Maryjane CerroneLehigh Valley Hospital

    Allentown, Pennsylvania, 18103-6208

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Johns Hopkins Pain Center

    Baltimore, Maryland, 21205

  • North Shore University Hospital

    Bethpage, New York, 11554

  • University of Virginia Pain Management Center

    Charlottesville, Virginia, 22903

  • Rehab Institute of Chicago

    Chicago, Illinois, 60611

  • Research Institute of Greater Dayton

    Dayton, Ohio, 45432

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • University of Iowa

    Iowa City, Iowa, 52242

  • Loma Linda Institution

    Loma Linda, California, 92354

  • Texas Tech Medical Center Department of Anesthesiology

    Lubbock, Texas, 79430

  • Space Coast Neurology

    Palm Bay, Florida, 32905

  • Drexel University College of MedicineDepartment of Neurology Rm 7102

    Philadelphia, Pennsylvania, 19102

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • KRK Medical Research

    Richardson, Texas, 75080

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical CenterPain Services

    Rochester, New York, 14642

  • Swedish Pain Services

    Seattle, Washington, 98104

  • Fletcher Allen Healthcare for Pain Medicine

    South Burlington, Vermont, 05403

  • Washington University Pain Mgmt Ctr

    St Louis, Missouri, 63141

  • Genova Clinical Research, Inc

    Tucson, Arizona, 85741

  • Gold Coast Research, LLC

    Weston, Florida, 33331

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

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this 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

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.

Read the 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.

Conditions
Radiculopathy
Being tested
Lenalidomide (CC-5013)
Keywords
Radiculopathy, Back Pain, Lumbar Pain, CC-5013, Revlimid, Lenalidomide
Medical subject headings
Radiculopathy, Back Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide (CC-5013)Drug

    Also called Revlimid

    Lenalidomide 2-5 mg capsules taken one time per day

Study groups in NCT00120120
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Lenalidomide (CC-5013)
2ExperimentalNot described
Receives: Drug: Lenalidomide (CC-5013)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: baseline to week 12

Secondary outcomes (11)

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

    Measured: change from baseline

  2. Change from baseline in the PM PI NRS value

    Measured: change from baseline

  3. Change from baseline in the AM PI NRS value

    Measured: change from baseline

  4. Change from baseline inactivity level rating using an NRS

    Measured: change from baseline

  5. Change from baseline in SLR angle of elevation without induced pain

    Measured: change from baseline

  6. Change from baseline in the SF-MPQ total score and subscale scores

    Measured: change from baseline

  7. Changes from baseline in the BPI score relative to baseline pain ratings and interference scales

    Measured: change from baseline

  8. Changes from baseline in the POMS total mood score and six dimension subscale scores

    Measured: change from baseline

  9. Change from baseline in the PDI score

    Measured: change from baseline

  10. Change from baseline in the Modified Oswestry Low Back Pain Disability Questionnaire total score

    Measured: change from baseline

  11. Patient global impression of change

    Measured: change from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionOct 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120120
Sponsor's protocol ID
CC-5013-RAD-001
Status last verified
Sep 2009
First submitted
8 Jul 2005
Last updated
23 Sep 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27550953

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Lenalidomide (CC-5013) in people with Radiculopathy, run by Celgene Corporation at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in RAD pain intensity ratings using PI-NRS (time frame: baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00120120, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009.

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