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Continuous Intrathecal Baclofen Infusion for Chronic Spasticity

NCT01051128 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-03-06

No results posted yet for this study

Summary

The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.

Conditions

  • Spasticity

Interventions

DEVICE

Prometra Programmable Implantable Pump System

The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer.

Sponsors & Collaborators

  • Flowonix Medical

    lead INDUSTRY

Principal Investigators

  • Robert Levy, MD, PhD · Northwestern University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-06-30
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051128 on ClinicalTrials.gov