Research

Space Coast Neurology is currently involved in the following projects:

1. Review of CRPS patients in possible "remission".

2. A nationwide study of a new drug for the treatment of CRPS Type 1.

3. A nationwide study of a new drug for the treatment of Painful Lumbar Radiculopathy.

Medical Research For The Treatment of CRPS Type I

Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1.

Sponsored by: Celgene Corporation

Purpose

This is a multi-center, 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 10mg per day of Lenalidomide or placebo (90 subjects per treatment). For each subject, the subject consists of three phases. Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and Extension Phase (up to 52 weeks).

Condition	Treatment or Intervention	Phase
Complex Regional Pain Syndrome (RSD) Type 1	Drug: Lenalidomide	Phase II

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:

	At least eight PI-NRS scores during this 7-day period are required and
	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.

Negative drugs of abuse screen (except drugs known to be prescribed for radiculopathy).

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.

A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).

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.

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.

	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.
	Documented metabolic or toxic peripheral 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 T3, T4 or TSH test values at Visit 1.

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 us of a spinal cord stimulator or intrathecal drug infusion device.

Limited duration (planned termination during either the Pre-randomization or Treatment Phase) non-drug therapies (including physical therapy, acupuncture and chiropractic treatments) during 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.

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.

Presence of a clinically significant psychiatric diagnosis(es) that would impair reliable study participation.

History of low back or lumbar spinal surgery.

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.

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 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. and pending litigation or pending proceedings), compensation or disability issues related to painful lumbar radiculopathy (Subjects whose cases have been settled or finally decided are eligible)

If you feel you meet the above criteria for inclusion in this study and are interested in participating or would like more information please contact our office (321) 984-7997. Dr. Hashmi, the study investigator or Pauline Cobble the site coordinator will be more than happy to assist you.