Multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of Lenalidomide in the treatment of CRPS I

Sponsored by Celgene Corporation

Purpose
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 (up to 52 weeks). Subjects will have the opportunity to receive lenalidomide treatment as long as a benefit is derived from the drug.

Study Type: Interventional

Study Design: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Group Assignment, Safety/Efficacy Study in adult subjects with CRPS Type 1.

Further Study Details: Expected Total Enrollment: 180

Study start: January, 2005; Study completion: January, 2007

Eligibility

Ages Eligible for Study: 18 years and above; Genders Eligible for Study: Both

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 (IASP) Criteria (Appendix I) for at least one-year duration. Either unilateral or bilateral involvement of the distal limb (hand or foot) with or without proximal spread must be present. In the presence of upper and lower or bilateral limb involvement, the most severely affected limb (based on IASP criteria) 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) 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:
  a. At least eight PI-NRS scores during this 7-day period are
  required and
  b. 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 in the non-affected limb 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 interourse or to use two methods of contraception beginning 4 weeks prior to the start of the study drug (Day 1) while on study drug (inlcuding dose interruptions) and 4 weeks after the last dose of study drug. The two methods of contraception must include one highly effective method (ie, 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 (ie, latex condoms, 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 childbearning potential (WCBP)† must have two negative pregnancy tests (sensitivity of at least 50 mlU/mL) prioir to starting study drug treatment. The first test should be perfomed 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 (periods following Visit 2 and Visit 7). Thereafter, subjects are required to have pregnancy testing every 4 weeks in females s with menstrual cycles and every 2 weeks if cycles are irregular.
• 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 109 / 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), including steroid-based
  contraceptives (oral, injectable or implanted) and hormone replacement
  therapies which could increase the risk for developing DVT.
• 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.

Location Information

Updated March 17, 2006