NCT01520545

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Piramal Critical Care, Ltd. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Severe Spasticity

Interventions

Type	Name	Description
DRUG	Gablofen® 3 mg/mL (baclofen injection)	This is a prospective twelve-month Phase IIIb clinical safety trial followed by a 2-year, Phase IV study that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. 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.
DEVICE	SynchroMed® II Programmable Pump	Intrathecal programmable pump

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-08-01
• Completion: 2016-10-01
• First posted: 2012-01-30
• Last updated: 2019-05-03

Locations

13 sites across 1 country: United States