Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump

Severe Spasticity Clinical Trial

Official title: Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System

Status Completed

Clinical Trial Summary

Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump

Clinical Trial Description

This is a prospective 36-month Phase IIIb/IV clinical safety trial that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. All patients will be entered after signing an IRB approved informed consent. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated. Patients will be evaluated for clinical complications associated with the use of intrathecal baclofen that are considered signs and symptoms of an inflammatory granuloma, specifically new radicular pain at the level of the catheter tip, and/or spinal cord compression. An MRI scan with and without infusion will be performed (with consent of the patient) to evaluate the potential presence of an inflammatory granuloma if clinical signs exist. Events that may be related to an inflammatory granuloma will be classified as a definite granuloma, possible granuloma, other catheter related problem (confirmed not caused by a granuloma), or other clinical sequelae caused by the underlying disease or other infusion system related event. ;

Related Conditions & MeSH terms

• Severe Spasticity

• NCT number: NCT01520545
• Study type: Interventional
• Source: Piramal Critical Care, Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Completion date: October 2016