An Open-Label, Sequential, Dose Escalation Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy
Overview
- Phase
- Phase 2
- Intervention
- MDT-15
- Conditions
- Sciatica
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 54
- Locations
- 6
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
MDT-15
The treatments will be administered to separate, sequential cohorts of 18 treated subjects in the following escalating doses:1 pellet, 3 pellets, and 6 pellets.
Intervention: MDT-15
Outcomes
Primary Outcomes
Cmax
Time Frame: 84 days
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
Tmax
Time Frame: 84 days
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
AUC0-t
Time Frame: 84 days
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
AUC0-∞
Time Frame: 84 days
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
Incidence of Adverse Events
Time Frame: 364 days
Incidence of Adverse Events as a Measure of Safety.
Secondary Outcomes
- Change in Radicular Leg Pain(Baseline and 364 days)
- Change in Work Function(Baseline and 84 days)
- Change in Physical Function(Baseline and 364 days)
- Change in Back Pain(Baseline and 364 days)
- Change in Neuropathic Type Symptoms(Baseline and 84 days)
- Change in Medical Outcomes study - Sleep Scale(Baseline and 84 days)
- Change in Emotional Function(Baseline and 84 days)
- Global Rating of Improvement(84 days)