Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1

NCT00109772 | Terminated Phase 2 Results DMC

• 1 other identifier: CC-5013-CRPS-002
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 27

Brief Summary

The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.

Conditions

Complex Regional Pain Syndrome, Type I

Keywords

CRPS; RSDS; Pain; CC-5013; Revlimid; Complex Regional Pain Syndrome; Reflex Sympathy Dystrophy Syndrome; Lenalidomide; CRPS Type I; Celgene

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment

  Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.

  Day 0, Week 12

Secondary Outcomes (16)

• Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12

  Day 0, week 12

• Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12

  Day 0, week 12

• Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12

  Day 0, week 12

• Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12

  Day 0, week 12

• Change From Baseline in Daily Sleep Assessment Average Score at Week 12

  Day 0, week 12

Study Arms (2)

lenalidomide

EXPERIMENTAL

10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.

Drug: lenalidomide

Placebo

PLACEBO COMPARATOR

Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.

Drug: Placebo

Interventions

lenalidomide DRUG

Two 5 mg capsules taken one time per day

Also known as: Revlimid, CC-5013

lenalidomide

Placebo DRUG

Two placebo capsules taken one time per day

Placebo

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 at the time of signing the informed consent form
• Understand and voluntarily sign an informed consent form
• A diagnosis of CRPS Type 1, as defined by modified International Association for the Study of Pain criteria for at least a one-year duration. Unilateral involvement of a distal limb (hand or foot) with or without proximal spread must be present. In the presence of upper and lower limb involvement, the most severely affected limb will be designated the CRPS-affected limb.
• Screening: CRPS pain intensity score in the CRPS-affected limb must be at least 4 on an 11-point (0-10) Pain Intensity Numerical Rating Scale (PI-NRS).
• Randomization: Average 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 PI-NRS scores during this 7-day period are required and the Average PI-NRS score in the CRPS-affected limb during this period must be at least 4 on an 11-point (0-10) PI-NRS.
• Measurable (by electrophysiology methods) sural, median sensory, median motor and peroneal motor nerves at the screening nerve conduction study.
• Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided that the subject is on stable doses/regimens for at least four weeks prior to the start of the Treatment Phase (Visit 2).
• Able to adhere to the study visit schedule and other protocol requirements.
• 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 \[IUD\], 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 test 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:

• The presence of any of the following will exclude a subject from study enrollment:
• History of deep vein thrombosis (DVT) or stroke in the past 5 years.
• Documented peripheral neuropathies to include diabetic neuropathy and other metabolic or toxic neuropathies.
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease.
• Any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• White blood cell count (WBC) \< 3.5\*10\^9/L at screening.
• Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase levels more than two times the upper limit of the normal range at screening.
• Abnormal thyroid function test values at screening.
• Any 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.
• Use of concomitant medication(s), 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.
• Concurrent use of thalidomide.
• Prior development of an allergic reaction/hypersensitivity while taking thalidomide.
• Prior development of a moderate or severe rash or any desquamation while taking thalidomide.
• Prior treatment with lenalidomide.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (27)

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

UCSD Center for Pain and Palliative Medicine

La Jolla, California, 92093, United States

Location

Loma Linda Institution

Loma Linda, California, 92354, United States

Location

Space Coast Neurology

Palm Bay, Florida, 32905, United States

Location

Northwestern University

Chicago, Illinois, 60611-2908, 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 Hospital

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University Pain Mgmt Ctr

St Louis, Missouri, 63141, United States

Location

Hospital for Joint Disease

New York, New York, 10003, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

UNC Hospitals University of North Carolina

Chapel Hill, North Carolina, 27599-7010, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, 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

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Knobler Institute of Neurologic Disease

Fort Washington, Pennsylvania, 19034, United States

Location

Drexel University College of Medicine Department of Neurology Rm 7102

Philadelphia, Pennsylvania, 19102, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Tech Medical Center Department of Anesthesiology

Lubbock, Texas, 79430, 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, Alexander G, Arezzo JC, Cooper A, Harden RN, Oaklander AL, Raja SN, Rauck R, Schwartzman R. Lenalidomide for complex regional pain syndrome type 1: lack of efficacy in a phase II randomized study. J Pain. 2014 Dec;15(12):1366-76. doi: 10.1016/j.jpain.2014.09.013. Epub 2014 Oct 2.

  PMID: 25283471 DERIVED

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy; Pain; Complex Regional Pain Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; 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

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Donald C Manning, MD, PhD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 28, 2013
• Results First Posted: August 28, 2013

Record last verified: 2013-08

Locations

US (27)