MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LENALIDOMIDE IN THE TREATMENT OF COMPLEX REGIONAL PAIN SYNDROME TYPE 1
Two members of the Foundation's Scientific Advisory Committee are Principal Investigators in the following well-controlled clinical trial on lenalidomide in patients with RSD / CRPS.
Preliminary results from research on lenalidomide are encouraging. Celgene recently amended the protocol to include bilateral as well as unilateral subjects and they are also looking into the possibility of adding on some additional sites.
Sponsored by: Celgene Corporation
Information provided 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).
MedlinePlus related topics: Reflex Sympathetic Dystrophy
Study Type: Interventional
Study Design: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Group Assignment, Safety/Efficacy Study.
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
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 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) 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 have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. The use of steroid-based contraceptives (oral, injectable or implanted) is not permitted in this study. WCBP must agree to have pregnancy tests every 4 weeks while on 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
State
Principal Investigator
Institution
Arizona
Dr.Louis Kirby, 623-815-9714
Pivotal Research Centers, Peoria, Arizona 85381
California
Dr. Lowell Reynolds
909-558-6280
Loma Linda Institution, Loma Linda, California, 92354
Dr. Mark Wallace
858-647-7030
UCSD Center for Pain and Palliative Medicine, La Jolla, California, 92093
Florida
Dr.Masood Hashmi
321-984-7997
Space Coast Neurology, Palm Bay, Florida 32905
Illinois
Dr.Norman Harden
312-238-7878
Rehab Institute of Chicago, Chicago, Illinois, 60611
