Continuous Intrathecal Baclofen Infusion for Chronic Spasticity "CIBI"


Phase 3 Results N/A

Summary of Purpose

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. Trial Stopped: Study was never started. Full IDE-approval not obtained. new IDE will be submitted

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 5 March 2015.

1 Jan 2010 15 Jan 2010 1 Jun 2010 1 Dec 2010 1 Mar 2015 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Basics




Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment


Not available