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

NCT01917825 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: P12-06
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

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.

Conditions

Sciatica; Lumbosacral Radiculopathy

Keywords

radicular pain

Outcome Measures

Primary Outcomes (5)

• Cmax

  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.

  84 days

• Tmax

  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.

  84 days

• AUC0-t

  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.

  84 days

• AUC0-∞

  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.

  84 days

• Incidence of Adverse Events

  Incidence of Adverse Events as a Measure of Safety.

  364 days

Secondary Outcomes (8)

• Change in Radicular Leg Pain

  Baseline and 364 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

Study Arms (1)

MDT-15

EXPERIMENTAL

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.

Drug: MDT-15

Interventions

MDT-15 DRUG

MDT-15

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (6)

Holy Cross Orthopedic Institute

Fort Lauderdale, Florida, 33334, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Franciscan St Francis Pain and Spine Center

Indianapolis, Indiana, 46237, United States

Location

Otrimed Clinical Research

Edgewood, Kentucky, 41017, United States

Location

Pain and Rehabilitation Specialists

St Louis, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Sciatica

Interventions

MDT-15 protein, C elegans

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 7, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-02

Locations

US (6)