Research

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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

bulletAge ›18 years at the time of signing the informed consent form

 

bulletUnderstand and voluntarily sign an informed consent form

 

bulletA 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.

 

bulletScreening (Visit 1): CRPS pain intensity score in the CRPS-affected limb
must be at least 4 on an 11-point (0-10) PI-NRS

 

bulletRandomization (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:
bulletAt least eight PI-NRS scores during this 7-day period are
required and
bulletAverage PI-NRS score in the CRPS-affected limb during this
period must be at least 4 on an 11-point (0-10) PI-NRS.

 

bulletMeasurable (by electrophysiology methods) sural, median sensory,
median motor and peroneal motor nerves at the screening nerve
conduction study.

 

bulletOpioid 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).

 

bulletAble to adhere to the study visit schedule and other protocol
requirements.

 

bulletWomen 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.
bulletA 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:

bulletHistory of deep vein thrombosis (DVT) or stroke in the past 5 years.

 

bulletDocumented peripheral neuropathies to include diabetic neuropathy
and other metabolic or toxic neuropathies.

 

bulletCurrent signs or symptoms of severe, progressive or uncontrolled renal,
hepatic, hematological, endocrine, pulmonary, cardiac, neurological or
cerebral disease.

 

bulletAny other serious medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from signing the
informed consent form.

 

bulletWhite blood cell count (WBC) < 3.5 x 109 / L at Visit 1.

 

bulletBilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or
alkaline phosphatase levels more than two times the upper limit of the
normal range at Visit 1.

 

bulletAbnormal thyroid function test values at Visit 1.

 

bulletAny 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.

 

bulletUse of concomitant medication(s), including steroid-based
contraceptives (oral, injectable or implanted) and hormone replacement
therapies which could increase the risk for developing DVT.

 

bulletConcurrent use of thalidomide.

 

bulletPrior development of an allergic reaction/hypersensitivity while taking
thalidomide.

 

bulletPrior development of a moderate or severe rash or any desquamation
while taking thalidomide.

 

bulletPrior treatment with Lenalidomide.

 

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.

 

 

Medical Research For Painful Lumbar Radiculopathy

 

Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy.

 

Sponsored by: Celgene Corporation

 

Purpose

 

This is a multi-center, double blind, placebo-controlled study in adult subjects with Painful Lumbar Radiculopathy.

One hundred eighty (180) subjects diagnosed with Painful Lumbar Radiculopathy. 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 54 weeks).

 

Condition

Treatment or Intervention

Phase

Painful lumbar radiculopathy

Drug: Lenalidomide

Phase II

 

Study Type

Interventional

Study Design

Multicenter, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy and Safety of Lenalidomide In The Treatment Of Painful Lumbar Radiculopathy

Further Study Details

Expected Total Enrollment

180

Study start

June 2005

Study completion

2007

Eligibility

Ages Eligible for Study

18 years and above

Genders Eligible for Study

Both

 

Criteria

Inclusion Criteria

bullet Age ›18 years at the time of signing the informed consent form

 

bullet Understand and voluntarily sign an informed consent form

 

bullet Clinical diagnosis of painful lumbar radiculopathy which is based on the presence of pain in the distribution of the sciatic nerve or L4, L5 or S1 dermatomes. The pain must be primarily in the lower leg and radiation to the ankle or foot.

 

bullet History of painful lumbar radiculopathy involving one or both of the distal lower extremities for › 6 months.

 

bullet MRI or CT scan within the past 2 years or more recent if symptoms have changed.

 

bullet Positive straight leg raising (SLR) test in the index ipsilateral leg (pain radiating below the knee at an elevation of <600). In the presence of bilateral leg pain, the leg with the most severe pain will be designated the index leg.

 

bullet Screening (Visit 1): Radiculopathy PI-NRS score must be at least 5 on an 11-point (0-10).

 

bullet 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:
bullet At least eight radiculopathy PI-NRS scores during this 7-day period are
required and
bullet Average radiculopathy PI-NRS score in the -affected limb during this
period must be at least 4 on an 11-point (0-10) PI-NRS.

 

bullet 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).

 

bullet Able to adhere to the study visit schedule and other protocol
requirements.

 

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

 

bullet 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.
bullet 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:

bullet History of deep vein thrombosis (DVT) or stroke in the past 5 years.

 

bullet 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.

 

bullet Ankle or foot problems, which could interfere with the assessment of radiculopathy pain.
bullet Unstable lumbar spinal segment.

 

bullet Evidence of an acute operable lesion or tumor based on CT scan or MRI results.
bullet Documented metabolic or toxic peripheral neuropathies.

 

bullet Current signs or symptoms of severe, progressive or uncontrolled renal,
hepatic, hematological, endocrine, pulmonary, cardiac, neurological or
cerebral disease.

 

bullet Any other serious medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from signing the
informed consent form.

 

bullet White blood cell count (WBC) < 3.5 x 109 / L at Visit 1.

 

bullet 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.

 

bullet Abnormal T3, T4 or TSH test values at Visit 1.

 

bullet More than 6 epidural steroid injections within the 12 months prior to randomization (Visit 2).

 

bullet Use of an epidural steroid injection within 28 days of randomization.

 

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

 

bullet 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.

 

bullet 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.

 

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

 

bullet History of low back or lumbar spinal surgery.

 

bullet 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.

 

bullet Use of oral corticosteroids (except for asthma inhalers and Medrol Dosepak) within 28 days prior to randomization.

 

bullet Concurrent use of thalidomide.

 

bullet Prior development of an allergic reaction/hypersensitivity while taking
thalidomide.

 

bullet Prior treatment with Lenalidomide.

 

bullet Use of any other experimental drug or therapy within 28 days of the start of the treatment phase.

 

bullet Current pregnancy or lactation.

 

bullet History of poor compliance or the inability to comply with medical regimens or study requirements.

 

bullet Inability to use an electronic diary.

 

bullet 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.

 

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