A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy

Completed · Phase 2

Conditions studied: Sciatica, Lumbosacral Radiculopathy

In brief

The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment.

Key facts

Study ID

NCT01917825

Run by

Medtronic Spinal and Biologics

People needed

54

Starts

2013-07-01

Expected to finish

2016-10-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be male or female at least 18 years of age.
• Have radiating pain toward the buttock down to the leg and/or feet, unilateral.
• Have radiologic pathology change from L1 - S1 consistent with a disc protrusion, non-sequestered extrusion, or sequestered fragment, as evidenced by magnetic resonance imaging (MRI), that is consistent with the clinical signs and symptoms of lumbar radiculopathy. The MRI must have been performed within 2 months prior to screening or it will need to be repeated.
• Have primary leg pain with an average NRS score equal to or greater than 5 as measured twice a day for five days in each of two weeks during screening.
• Have failed conservative care for at least 6 weeks. The subject must have been treated non-operatively (e.g., bed rest, physical therapy, medications, TENS, and/or manipulation) for a period of at least 6 weeks.
• Be willing to stop current anti-inflammatory therapy taken for treatment of radicular pain.
• Be willing and able to keep a diary that will record study-related information.
• If sexually active female of childbearing potential, be willing to use an acceptable method of birth control during the study. Acceptable methods include oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide. Surgical sterilization by tubal ligation or hysterectomy is acceptable. Women of child bearing potential are defined as women who are <12 months since their last menstrual cycle prior to screening and have not experienced surgical menopause.
• Be able to understand the study and provide written informed consent.

You may not qualify if…

• Have a history of lumbar surgery, including vertebroplasty and kyphoplasty.
• Be ≤ 6 weeks after lumbar ESI or nerve block at start of screening.
• Have current radicular pain for more than 6 months.
• Have more than one epidural steroid injection at the affected level to be treated within the last 6 months.
• Have demonstrated radiographic changes consistent with subject's symptoms at more than one level on the baseline MRI.
• Have symptomatic spinal stenosis of central origin at any level based on CT myelogram or MRI.
• Have pain that is localized in the lower back or other sites and is a greater component of the subject's total pain than the pain in the lower leg and/or foot.
• Have physical problems that may interfere with any study assessments.
• Have known infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
• Have presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years (history of basal cell carcinoma will be allowed).
• Have impaired renal function (creatinine >1.5 times upper limit of normal).
• Have chronic impairment liver function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times upper limit of normal).
• Have insulin-dependent diabetes or uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c] >7%).
• Have leukopenia (<3,500 leukocytes/uL).
• Have current orthostatic hypotension (defined as systolic blood pressure decrease of at least 20 mmHg or a diastolic blood pressure decrease of at least 10 mmHg or an increase in heart rate by 20 beats per minute within 3 minutes of standing).
• Have clinically significant risk for hypotension (e.g., hypotension defined as systolic reading <90 mmHg and/or diastolic <60 mmHg, hypovolemia, autonomic neuropathy, or other medical conditions affected by changes in blood pressure).
• Any clinically significant cardiovascular condition as evidenced by physical exam, medical history and/or baseline electrocardiogram (ECG).
• Have evidence of bradycardia as shown by heart rate of <60 beats per minute via screening ECG.
• Have any poorly-controlled or serious medical condition, psychiatric illness, or clinically significant laboratory value that, in the opinion of the investigator, could compromise the safety of the subject or the scientific integrity of the study (e.g., uncontrolled hypertension, autoimmune disease, or clinically relevant symptoms of thyroid dysfunction).
• Have cauda equina syndrome.
• Have neurological deficits, as determined by the investigator, which would interfere with the assessments required by the protocol.
• Have been previously diagnosed with peripheral neuropathy.
• Have vascular claudication, as determined by the investigator, which would interfere with the assessments required by the protocol.
• Have a history or evidence of bleeding disorder (e.g., hemophilia, disseminated intravascular coagulation disorder [DIC], or thrombocytopenia [TCP])
• Have greater than 3 mm spondylolisthesis at the affected level.

Where it is running

• Holy Cross Orthopedic Institute — Fort Lauderdale, Florida, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Franciscan St Francis Pain and Spine Center — Indianapolis, Indiana, United States
• Otrimed Clinical Research — Edgewood, Kentucky, United States
• Pain and Rehabilitation Specialists — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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