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Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1 (CRPS-002)
This study has been completed.
First Received: May 3, 2005   Last Updated: October 21, 2008   History of Changes
Sponsored by: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00109772
  Purpose

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.


Condition Intervention Phase
Complex Regional Pain Syndrome, Type I
Drug: lenalidomide (CC-5013)
Drug: Placebo
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Efficacy [ Time Frame: first 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: February 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Placebo Control Arm
Drug: Placebo
5mg matching placebo. 2 capsules taken 1 time per day
Active Arm: Experimental
Active arm
Drug: lenalidomide (CC-5013)
5 mg capsules, 2 5mg capsules taken one time per day

Detailed Description:

This is a multicenter, double-blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1. One hundred eighty (180) subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mg/day of lenalidomide or placebo (90 subjects per treatment arm). For each subject, the study consists of three phases: Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and Extension Phase where subjects have the opportunity to receive lenalidomide treatment as long as a benefit is derived from the drug. Subjects who complete all 12 weeks of the treatment phase may be eligible to receive lenalidomide in the extension phase. Subject 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 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 (Visit 1): 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 (Visit 2): Average PI-NRS score for randomization purposes (Visit 2) 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, 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.

Exclusion Criteria:

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 x 10^9/L at Visit 1.
  • Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase levels more than two times the upper limit of the normal range at Visit 1.
  • Abnormal thyroid function test values at Visit 1.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109772

  Show 27 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Donald C Manning, MD, PhD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation ( Donald Manning, MD, PhD, Vice President Clinical Research and Development )
Study ID Numbers: CC-5013-CRPS-002
Study First Received: May 3, 2005
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00109772     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
CRPS
RSDS
Pain
CC-5013
Revlimid
Complex Regional Pain Syndrome
Reflex Sympathy Dystrophy Syndrome
Lenalidomide
CRPS Type I
Celgene
Lenalidomide

Study placed in the following topic categories:
Autonomic Nervous System Diseases
Reflex Sympathetic Dystrophy
Neuromuscular Diseases
Complex Regional Pain Syndromes
Mental Disorders
Peripheral Nervous System Diseases
Lenalidomide
Reflex Sympathetic Dystrophy Syndrome
Pain
Somatoform Disorders

Additional relevant MeSH terms:
Reflex Sympathetic Dystrophy
Disease
Antineoplastic Agents
Nervous System Diseases
Lenalidomide
Pharmacologic Actions
Autonomic Nervous System Diseases
Pathologic Processes
Complex Regional Pain Syndromes
Neuromuscular Diseases
Mental Disorders
Therapeutic Uses
Syndrome
Peripheral Nervous System Diseases
Somatoform Disorders

ClinicalTrials.gov processed this record on September 03, 2009