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NCT01917825 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Sciatica and Lumbosacral Radiculopathy, sponsored by Medtronic Spinal and Biologics.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
6
Study locations

NCT01917825 is a Phase 2 study of Sciatica and Lumbosacral Radiculopathy that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 54 participants, below the 78-participant average among 6 other Sciatica trials with a reported enrollment target (31% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT01917825, a Phase 2 study of Sciatica and Lumbosacral Radiculopathy, has completed, sponsored by Medtronic Spinal and Biologics.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
6
Study locations

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

Sciatica Lumbosacral Radiculopathy

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

FieldValue
Enrollment Target 54 participants
Start Date 2013-07
Est. Completion 2016-10
Phase Phase 2

Sponsor

Medtronic Spinal and Biologics

26 total trials

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What the Registry Record Tells You About NCT01917825

The ClinicalTrials.gov registry entry for NCT01917825 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 78-participant average among 6 other Sciatica trials with a reported enrollment target (31% lower). The listed sponsor is Medtronic Spinal and Biologics, which has 26 total studies on file at ClinicalTrials.gov.

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.

NCT01917825 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Indiana, Florida, Illinois.

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.

What interventions are being tested in trial NCT01917825?

The interventions under investigation include: MDT-15 (DRUG).

Who is sponsoring clinical trial NCT01917825?

This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.