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A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy
NCT01917825 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG MDT-15
Study Locations (6)
Indiana
- Indiana Spine Group — Carmel
- Franciscan St Francis Pain and Spine Center — Indianapolis
Florida
- Holy Cross Orthopedic Institute — Fort Lauderdale
Illinois
- Millennium Pain Center — Bloomington
Kentucky
- Otrimed Clinical Research — Edgewood
Missouri
- Pain and Rehabilitation Specialists — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01917825
The ClinicalTrials.gov registry entry for NCT01917825 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Spinal and Biologics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Sciatica appearing as the primary indexed condition, and to 1 intervention — of which MDT-15 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01917825 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Indiana, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01917825 about?
NCT01917825 is a clinical study titled "A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy". 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.
What is the current status of trial NCT01917825?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2013-07. Estimated completion is 2016-10.
What conditions does trial NCT01917825 study?
This clinical trial studies the following conditions: Sciatica, Lumbosacral Radiculopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01917825?
The interventions under investigation include: MDT-15 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01917825?
This trial is sponsored by Medtronic Spinal and Biologics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01917825 being conducted?
This trial has 6 study locations across Florida, Illinois, Indiana, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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