A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy
NCT01917825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2017-04-20
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
Interventions
- DRUG
-
MDT-15
Sponsors & Collaborators
-
Medtronic Spinal and Biologics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2015-10-31
- Completion
- 2016-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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